Orthopedic Elevator Suppliers
Limit companies to: Worldwide USA
Equip For Independence, Inc. | Address: 333 Mamaroneck Avenue, Suite 383, White Plains, New York 10605-1440, USA 
www.liftalimb.com | Send Inquiry | Phone: +1-(914)-328-7230, 800-216-4881
Year Established: 1992
Products: Adjustable Elbow Support, Foot Support, Basic Elbow Support, Foot Support Positioning System, Elastic Elbow Support, Arthroscopy Leg Holder, ...
Equip For Independence, Inc. specializes in surgical appliances and supplies. Our medical devices are used in hospitals, surgical centers, wound treatment centers, sports medicine, medical offices and more...
www.liftalimb.com | Send Inquiry | Phone: +1-(914)-328-7230, 800-216-4881
Year Established: 1992
Products: Adjustable Elbow Support, Foot Support, Basic Elbow Support, Foot Support Positioning System, Elastic Elbow Support, Arthroscopy Leg Holder, ...
Equip For Independence, Inc. specializes in surgical appliances and supplies. Our medical devices are used in hospitals, surgical centers, wound treatment centers, sports medicine, medical offices and more...
Aesculap Implant Systems, Inc. | Address: #3773, Corporate Parkway, Center Valley, Pennsylvania 18034, USA
www.aesculapimplantsystems.com | Send Inquiry | Phone: +1-(610)-984-9081, 800-234-9179
FDA Registration: 3005739625
Products: Small Depth Gauge (FDA Code: HTJ), Flexible Depth Gauge (FDA Code: HTJ), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Aesculap Implant Systems, Inc. offers a complete line of implant systems and instrumentation for the spine & orthopedic markets. Our orthopedic products include OrthoPilot® navigation system, Colu more...
www.aesculapimplantsystems.com | Send Inquiry | Phone: +1-(610)-984-9081, 800-234-9179
FDA Registration: 3005739625
Products: Small Depth Gauge (FDA Code: HTJ), Flexible Depth Gauge (FDA Code: HTJ), Orthopedic Manual Surgical Instrument (FDA Code: LXH), Spinal Interlaminal Fixation Appliance (FDA Code: KWP), Spinal Pedicle Fixation Orthosis (FDA Code: MNI), Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH), ...
Aesculap Implant Systems, Inc. offers a complete line of implant systems and instrumentation for the spine & orthopedic markets. Our orthopedic products include OrthoPilot® navigation system, Colu more...
In'Tech Medical, Incorporated | Address: 2851, Lamb Place, Suite 15, Memphis, Tennessee 38118, USA
Phone: +1-(901)-375-1109
Products: General use Surgical Curettes (FDA Code: FZS), Surgical Curette (FDA Code: FZS), Calipers (FDA Code: KTZ), Orthopedic Elevator (FDA Code: HTE), Orthopedic Manual Surgical Instrument (FDA Code: LXH), ...
In'Tech Medical, Incorporated specializes in providing surgical curettes, calipers and orthopedic elevators. more...
Phone: +1-(901)-375-1109
Products: General use Surgical Curettes (FDA Code: FZS), Surgical Curette (FDA Code: FZS), Calipers (FDA Code: KTZ), Orthopedic Elevator (FDA Code: HTE), Orthopedic Manual Surgical Instrument (FDA Code: LXH), ...
In'Tech Medical, Incorporated specializes in providing surgical curettes, calipers and orthopedic elevators. more...
Tedan Surgical Innovations, LLc | Address: 11333, Chimney Rock Road, Suite 180, Houston, Texas 77035, USA
www.tedansurgical.com | Send Inquiry | Phone: +1-(713)-726-0886/877-726-0886
FDA Registration: 3005726885
Products: Forceps (FDA Code: HTD), Retractors, General use Surgical Curettes (FDA Code: FZS), ENT Forceps (FDA Code: KAE), General & Plastic Surgery Surgical Dissector (FDA Code: GDI), Surgical Bit (FDA Code: GFG), ...
Tedan Surgical Innovations, LLc offers cervical products, lumbar products and distraction screws. Our distraction screw has a bullet shaped head, long self-tapping flute and a sharp tip, which provide more...
www.tedansurgical.com | Send Inquiry | Phone: +1-(713)-726-0886/877-726-0886
FDA Registration: 3005726885
Products: Forceps (FDA Code: HTD), Retractors, General use Surgical Curettes (FDA Code: FZS), ENT Forceps (FDA Code: KAE), General & Plastic Surgery Surgical Dissector (FDA Code: GDI), Surgical Bit (FDA Code: GFG), ...
Tedan Surgical Innovations, LLc offers cervical products, lumbar products and distraction screws. Our distraction screw has a bullet shaped head, long self-tapping flute and a sharp tip, which provide more...
Wexler Surgical | Address: 11333 Chimney Rock Road, Suite #120, Houston, Texas 77035, USA
www.wexlersurgical.com | Send Inquiry | Phone: +1-(713)-723-6900, 800-414-1076
FDA Registration: 1646747 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: CE Certified
Products: Bone Rasps (FDA Code: HTR), Bone Clamp (FDA Code: HXD), Blood Collection Sets with Needle Holder, Blood Needle Holder Systems, Calipers (FDA Code: KTZ), Cannula Clamp (FDA Code: FKC), ...
Wexler Surgical offers the specialty surgical instrumentation in titanium and stainless steel for ophthalmic surgery. Our wide range of products include forceps, needle holders, scissors, retractors, more...
www.wexlersurgical.com | Send Inquiry | Phone: +1-(713)-723-6900, 800-414-1076
FDA Registration: 1646747 Year Established: 1998 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: CE Certified
Products: Bone Rasps (FDA Code: HTR), Bone Clamp (FDA Code: HXD), Blood Collection Sets with Needle Holder, Blood Needle Holder Systems, Calipers (FDA Code: KTZ), Cannula Clamp (FDA Code: FKC), ...
Wexler Surgical offers the specialty surgical instrumentation in titanium and stainless steel for ophthalmic surgery. Our wide range of products include forceps, needle holders, scissors, retractors, more...
Ortopedia Para Ti | Address: , Mexico
https://ortopediaparati.com | Send Inquiry
Products: General Orthopedic Supplies, Orthopaedic Plates, Orthopaedic Instruments, Flexible Orthopaedic Solutions, Heavy Duty Orthopedic System, Custom Handles, Orthopedic, ...
Ortopedia Para Ti is an online orthopedic shop. We offer a wide range of products at disposal to help and solve different problems for all types of people. We have the latest models of wheelchairs, wa more...
https://ortopediaparati.com | Send Inquiry
Products: General Orthopedic Supplies, Orthopaedic Plates, Orthopaedic Instruments, Flexible Orthopaedic Solutions, Heavy Duty Orthopedic System, Custom Handles, Orthopedic, ...
Ortopedia Para Ti is an online orthopedic shop. We offer a wide range of products at disposal to help and solve different problems for all types of people. We have the latest models of wheelchairs, wa more...
JMF (T) Group Co., Ltd. | Address: 75/74 Moo 11, Paholyothin Rd., Klongnueng, Klongluang, Pathunthanee, TH-13 12120, Thailand
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Wire Cutters (FDA Code: HXZ), Surgical Instrument Tray (FDA Code: FSM), Endoscopic Television Camera (FDA Code: FWG), Endoscopic Television Camera without Audio (FDA Code: FWF), Non-Electric Biopsy Forceps (FDA Code: FCL), ...
JMF (T) Group Co., Ltd. specializes in manufacturing OEM medical devices. We provide large & small fragment implants and instruments. We also offer surgical power tools, sterile container systems, max more...
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Wire Cutters (FDA Code: HXZ), Surgical Instrument Tray (FDA Code: FSM), Endoscopic Television Camera (FDA Code: FWG), Endoscopic Television Camera without Audio (FDA Code: FWF), Non-Electric Biopsy Forceps (FDA Code: FCL), ...
JMF (T) Group Co., Ltd. specializes in manufacturing OEM medical devices. We provide large & small fragment implants and instruments. We also offer surgical power tools, sterile container systems, max more...
Synthes Gmbh | Address: Eimattstrasse 3, Oberdorf CH-4436, Switzerland
www.synthes.com | Send Inquiry | Phone: +41-(61)-9656666
FDA Registration: 8030965
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Laser Power Probe, Laparoscopic Probes, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ...
Synthes GmbH develops, produces and markets instruments, implants & biomaterials for the surgical fixation, correction & regeneration of the skeleton & its soft tissues. Trauma implants and instrument more...
www.synthes.com | Send Inquiry | Phone: +41-(61)-9656666
FDA Registration: 8030965
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Laser Power Probe, Laparoscopic Probes, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ...
Synthes GmbH develops, produces and markets instruments, implants & biomaterials for the surgical fixation, correction & regeneration of the skeleton & its soft tissues. Trauma implants and instrument more...
Ulrich Ag | Address: Movenstr 12, St. Gallen 9015, Switzerland
www.ulrich-swiss.ch | Send Inquiry | Phone: +41-(71)-314-6262
FDA Registration: 8039053 Employee Count: ~20 Quality: CE Certified
Products: Surgical Retractor Systems (FDA Code: GAD), Bulldog Clamps, Atrauma Bulldog Clamps, Bone Clamp (FDA Code: HXD), Carotid Bulldog Clamps, Surgical Retractor (FDA Code: GAD), ...
Ulrich Ag manufactures and distributes general & special surgical instruments and medical appliances. Our products include general & surgical instruments developed for surgeons. We offer servicing of more...
www.ulrich-swiss.ch | Send Inquiry | Phone: +41-(71)-314-6262
FDA Registration: 8039053 Employee Count: ~20 Quality: CE Certified
Products: Surgical Retractor Systems (FDA Code: GAD), Bulldog Clamps, Atrauma Bulldog Clamps, Bone Clamp (FDA Code: HXD), Carotid Bulldog Clamps, Surgical Retractor (FDA Code: GAD), ...
Ulrich Ag manufactures and distributes general & special surgical instruments and medical appliances. Our products include general & surgical instruments developed for surgeons. We offer servicing of more...
Stille AB | Address: Sundbybergsvagen 1A, Solna SE-171 73, Sweden
www.stille.se | Send Inquiry | Phone: +46-(8)-588-580-00
FDA Registration: 3003696170 Year Established: 1841
Products: Bone Rasps (FDA Code: HTR), Intramedullary Bone Rasps, Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Micro Ophthalmic Scissors, Ophthalmic Suture Scissors (FDA Code: HNF), ...
Stille AB specializes in surgical instruments. We deal with surgical instruments, headlights, retractor systems and specialty tables. Our bariatric retractor systems provide the surgeon with maximum s more...
www.stille.se | Send Inquiry | Phone: +46-(8)-588-580-00
FDA Registration: 3003696170 Year Established: 1841
Products: Bone Rasps (FDA Code: HTR), Intramedullary Bone Rasps, Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), Micro Ophthalmic Scissors, Ophthalmic Suture Scissors (FDA Code: HNF), ...
Stille AB specializes in surgical instruments. We deal with surgical instruments, headlights, retractor systems and specialty tables. Our bariatric retractor systems provide the surgeon with maximum s more...
Fabryka Narzedzi Medycznych | Address: Ul. Mstowska 8 A, Rudniki K/czestochowy 42-240, Poland
www.chirmed.pl | Send Inquiry | Phone: +48-(34)-320-14-84
FDA Registration: 3005587147
Products: Forceps (FDA Code: HTD), Bone Rasps (FDA Code: HTR), Human Bone Rasps (FDA Code: HTR), Adult Tongue Depressor (FDA Code: FMA), General & Plastic Surgery Surgical Spatula (FDA Code: GAF), Curettes (FDA Code: HTF), ...
Fabryka Narzedzi Medycznych manufactures surgical and medical instruments. more...
www.chirmed.pl | Send Inquiry | Phone: +48-(34)-320-14-84
FDA Registration: 3005587147
Products: Forceps (FDA Code: HTD), Bone Rasps (FDA Code: HTR), Human Bone Rasps (FDA Code: HTR), Adult Tongue Depressor (FDA Code: FMA), General & Plastic Surgery Surgical Spatula (FDA Code: GAF), Curettes (FDA Code: HTF), ...
Fabryka Narzedzi Medycznych manufactures surgical and medical instruments. more...
Accuray Surgicals Ltd. | Address: Lakson Square Bldg. #2, Sarwar Shaheed Rd., Karachi 74200, Pakistan
www.accuray.com.pk | Send Inquiry | Phone: +92-(21)-5681419
FDA Registration: 8040265 Year Established: 1981 Quality: ISO 9001:2000, ISO 13485:2003, CE Certified
Products: Adjustable Frequency Tuning Fork, Hertz Frequency Tuning Fork, Sensory Evaluation Tuning Fork, Aluminium Tuning Fork, Magnesium Tuning Forks, Tuning Forks (FDA Code: GWX), ...
Accuray Surgicals Ltd. deals with the manufacturing of surgical, dental and veterinary instruments. Our product list comprises of operating scissors, bandage scissors, thumb dressing forceps, retracto more...
www.accuray.com.pk | Send Inquiry | Phone: +92-(21)-5681419
FDA Registration: 8040265 Year Established: 1981 Quality: ISO 9001:2000, ISO 13485:2003, CE Certified
Products: Adjustable Frequency Tuning Fork, Hertz Frequency Tuning Fork, Sensory Evaluation Tuning Fork, Aluminium Tuning Fork, Magnesium Tuning Forks, Tuning Forks (FDA Code: GWX), ...
Accuray Surgicals Ltd. deals with the manufacturing of surgical, dental and veterinary instruments. Our product list comprises of operating scissors, bandage scissors, thumb dressing forceps, retracto more...
Combined Instruments (Pvt.), Ltd. | Address: 13-A Model Town, Ugoki, Sailkot, Pakistan
Phone: +92-(432)-510243
Products: Adenoid Punches (FDA Code: KBS), Adult Tongue Depressor (FDA Code: FMA), Adjustable Frequency Tuning Fork, A.V.Fistula Needle Set, A.V. Fistula Needle, Acoustical Fetal Holograph (FDA Code: HHX), ...
Combined Instruments (Pvt.), Ltd. is a manufacturer and exporter of general surgery instruments. Our products include cotton applicators, scalpel blades, depth gauge, ear speculum holders, biopsy & su more...
Phone: +92-(432)-510243
Products: Adenoid Punches (FDA Code: KBS), Adult Tongue Depressor (FDA Code: FMA), Adjustable Frequency Tuning Fork, A.V.Fistula Needle Set, A.V. Fistula Needle, Acoustical Fetal Holograph (FDA Code: HHX), ...
Combined Instruments (Pvt.), Ltd. is a manufacturer and exporter of general surgery instruments. Our products include cotton applicators, scalpel blades, depth gauge, ear speculum holders, biopsy & su more...
The Fazex Co. | Address: Po Gohadpur, Sialkot 22161, Pakistan
Products: Obstetrical Forceps (FDA Code: HDA), Titanium Ophthalmic Forceps, Scalpel Handle (FDA Code: GDZ), Dissecting Scalpel Handle, Titanium Beaver Scalpel Handle, Ophthalmic Forceps (FDA Code: HNR), ...
The Fazex Co. specializes in offering surgical and dental instruments. Our products include gastroenterologic needle holders, operating room table accessories, surgical hammers, scalpel handle, genera more...
Products: Obstetrical Forceps (FDA Code: HDA), Titanium Ophthalmic Forceps, Scalpel Handle (FDA Code: GDZ), Dissecting Scalpel Handle, Titanium Beaver Scalpel Handle, Ophthalmic Forceps (FDA Code: HNR), ...
The Fazex Co. specializes in offering surgical and dental instruments. Our products include gastroenterologic needle holders, operating room table accessories, surgical hammers, scalpel handle, genera more...
Dynamic Surgical (Pvt.) Ltd. | Address: Wazirabad Rd. Ugoki Industrial Area, Ugoki, Sialkot 51050, Pakistan
dynamic-surgical.com | Send Inquiry | Phone: +92-(52)-3571374
Annual Revenues: < USD 1 Million Employee Count: ~70 Quality: ISO 9001:2000, ISO 13485, CE Certified
Products: Obstetrical Forceps (FDA Code: HDA), ENT Syringe (FDA Code: KCP), Micro Ophthalmic Scissors, Baby Ear Syringe, Ophthalmic Suture Scissors (FDA Code: HNF), ENT Irrigation Syringe (FDA Code: KCP), ...
Dynamic Surgical (Pvt.) Ltd. is a manufacturer and exporter of surgical, dental, cardiovascular, orthopedic, spinal & neurosurgical instruments & implants. Our product list comprises of hemostatic for more...
dynamic-surgical.com | Send Inquiry | Phone: +92-(52)-3571374
Annual Revenues: < USD 1 Million Employee Count: ~70 Quality: ISO 9001:2000, ISO 13485, CE Certified
Products: Obstetrical Forceps (FDA Code: HDA), ENT Syringe (FDA Code: KCP), Micro Ophthalmic Scissors, Baby Ear Syringe, Ophthalmic Suture Scissors (FDA Code: HNF), ENT Irrigation Syringe (FDA Code: KCP), ...
Dynamic Surgical (Pvt.) Ltd. is a manufacturer and exporter of surgical, dental, cardiovascular, orthopedic, spinal & neurosurgical instruments & implants. Our product list comprises of hemostatic for more...
Himalaya Trading Co. (Pvt) Ltd. | Address: Wazirabad Road, Rai Pur, Sialkot 51051, Pakistan
himalaya-trading.com | Send Inquiry | Phone: +92-(52)-3514021
Annual Revenues: USD 100-500 Million Employee Count: ~80
Products: Obstetrical Forceps (FDA Code: HDA), ENT Syringe (FDA Code: KCP), Micro Ophthalmic Scissors, Baby Ear Syringe, Ophthalmic Suture Scissors (FDA Code: HNF), ENT Irrigation Syringe (FDA Code: KCP), ...
Himalaya Trading Co. (Pvt) Ltd. is a manufacturer & exporter of surgical, dental, manicure/pedicure and veterinary instruments. We also manufacture surgical hollow ware, knives of all sorts, scissors, more...
himalaya-trading.com | Send Inquiry | Phone: +92-(52)-3514021
Annual Revenues: USD 100-500 Million Employee Count: ~80
Products: Obstetrical Forceps (FDA Code: HDA), ENT Syringe (FDA Code: KCP), Micro Ophthalmic Scissors, Baby Ear Syringe, Ophthalmic Suture Scissors (FDA Code: HNF), ENT Irrigation Syringe (FDA Code: KCP), ...
Himalaya Trading Co. (Pvt) Ltd. is a manufacturer & exporter of surgical, dental, manicure/pedicure and veterinary instruments. We also manufacture surgical hollow ware, knives of all sorts, scissors, more...
Bukhsh International | Address: P.O.Box No 2313, Sialkot 51310, Pakistan
www.bukhsh.com | Send Inquiry | Phone: +92-(52)-4264335
FDA Registration: 3003454257
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Suture Forceps, Tonsil Snares (FDA Code: KBZ), Tonsil Forceps, Adenoid Curettes (FDA Code: KBJ), Trachea Dilating Forceps, ...
Bukhsh International offers surgical, dental, hair transplantation, and hollow ware products. We manufacture surgical instruments that are widely used in hospitals and surgery centers. We offer these more...
www.bukhsh.com | Send Inquiry | Phone: +92-(52)-4264335
FDA Registration: 3003454257
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Suture Forceps, Tonsil Snares (FDA Code: KBZ), Tonsil Forceps, Adenoid Curettes (FDA Code: KBJ), Trachea Dilating Forceps, ...
Bukhsh International offers surgical, dental, hair transplantation, and hollow ware products. We manufacture surgical instruments that are widely used in hospitals and surgery centers. We offer these more...
Win Wings Corp. | Address: 4 Small Industries Estates, Sialkot 22161, Pakistan
Phone: +92-(432)-256302
Products: Scalpel Handle (FDA Code: GDZ), General & Plastic Surgery Forceps (FDA Code: GEN), General Surgical Manual Instrument (FDA Code: MDM), General Surgical Scissors (FDA Code: LRW), Surgical Hammer (FDA Code: FZY), Metal Vaginal Speculum (FDA Code: HDF), ...
Win Wings Corp. is associated with curettes, dilators, general & plastic surgery forceps, metal speculum, and surgical hammers. more...
Phone: +92-(432)-256302
Products: Scalpel Handle (FDA Code: GDZ), General & Plastic Surgery Forceps (FDA Code: GEN), General Surgical Manual Instrument (FDA Code: MDM), General Surgical Scissors (FDA Code: LRW), Surgical Hammer (FDA Code: FZY), Metal Vaginal Speculum (FDA Code: HDF), ...
Win Wings Corp. is associated with curettes, dilators, general & plastic surgery forceps, metal speculum, and surgical hammers. more...
QSA Surgical (Pvt) Ltd. | Address: Ghuinke Daska Road .P.O.Box 1094, Sialkot 051310, Pakistan
Send Inquiry | Phone: +92-(432)-52 6387/6487/6587
FDA Registration: 8040233
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), General & Plastic Surgery Forceps (FDA Code: GEN), General Surgical Scissors (FDA Code: LRW), Uterine Packer (FDA Code: HDM), Hemostats (FDA Code: HRQ), Sterile ENT Wire Cutting Scissors (FDA Code: JYA), ...
QSA Surgical (Pvt) Ltd. specializes in surgical and dental instruments. Our product line includes amalgam carvers, dental cements, dental elevators, dental waxes, orthodonic band pashers, surgical spa more...
Send Inquiry | Phone: +92-(432)-52 6387/6487/6587
FDA Registration: 8040233
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), General & Plastic Surgery Forceps (FDA Code: GEN), General Surgical Scissors (FDA Code: LRW), Uterine Packer (FDA Code: HDM), Hemostats (FDA Code: HRQ), Sterile ENT Wire Cutting Scissors (FDA Code: JYA), ...
QSA Surgical (Pvt) Ltd. specializes in surgical and dental instruments. Our product line includes amalgam carvers, dental cements, dental elevators, dental waxes, orthodonic band pashers, surgical spa more...
Oraltech Instruments (Pvt) Ltd. | Address: Po Box #1600, Khan Villa, Cheema St Model Town, Sialkot, PK-PB 51310, Pakistan
Send Inquiry | Phone: +92-(52)-3555242
Quality: ISO 9001:2000 Certified
Products: Forceps (FDA Code: HTD), Rigid Laryngoscope (FDA Code: CCW), General & Plastic Surgery Surgical Spatula (FDA Code: GAF), Surgical Punch (FDA Code: LRY), Surgical Pliers (FDA Code: HTC), ENT Mirror (FDA Code: KAI), ...
Oraltech Instruments (pvt) Ltd. is a manufacturer of dental and surgical instruments. Our product line includes extracting forceps, root elevators, orthodontic pliers, filling instruments, bone curett more...
Send Inquiry | Phone: +92-(52)-3555242
Quality: ISO 9001:2000 Certified
Products: Forceps (FDA Code: HTD), Rigid Laryngoscope (FDA Code: CCW), General & Plastic Surgery Surgical Spatula (FDA Code: GAF), Surgical Punch (FDA Code: LRY), Surgical Pliers (FDA Code: HTC), ENT Mirror (FDA Code: KAI), ...
Oraltech Instruments (pvt) Ltd. is a manufacturer of dental and surgical instruments. Our product line includes extracting forceps, root elevators, orthodontic pliers, filling instruments, bone curett more...
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FDA Code / Regulation: HTE / 878.4800
A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9.
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