Profile: Biomet Microfixation manufactures a complete range of craniomaxillofacial products. We offer products for neurosurgical, plastic, oral & maxillofacial, craniofacial, pediatric, ENT and cardiothoracic applications. The RapidFlap™ LS system is a two-sided resorbable craniotomy fixation device. Its clamps are made of LactoSorb® co-polymer. This system provides an easy-to-use streamlined implant, which will be completely resorbed out of the body in one year. The Biomet Microfixation Midface 1.0 mm titanium system provides a rigid-fixation alternative for areas with high palpability and prominent bone formation. The areas include the frontal bone and the areas surrounding the orbit. The 1.0 mm plates feature a 0.6 mm profile allowing for minimal palpability while allowing for optimal stability in these areas. The system offers versatile plating options including generic meshes that can be used in neuro and craniofacial procedures.

The company was founded in 1965.

FDA Registration Number: 1032347

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• Gallstone Scoop (FDA Code: FHL / 876.4730) A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.

• Gastro-Urology Needle (FDA Code: FHR / 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.

• Gastro-Urology Probe and Director (FDA Code: FGM / 876.4730)

• General & Plastic Saw Surgical Blade (FDA Code: GFA / 878.4820) Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

• General & Plastic Surgery Forceps (FDA Code: GEN / 878.4800)

• General & Plastic Surgery Surgical Cannula (FDA Code: GEA / 878.4800)

• General & Plastic Surgery Surgical Clamp (FDA Code: GDJ / 878.4800)

• General & Plastic Surgery Surgical Dissector (FDA Code: GDI / 878.4800)

• General & Plastic Surgery Surgical Elevator (FDA Code: GEG / 878.4800)

• General & Plastic Surgery Surgical File (FDA Code: GEO / 878.4800)

• General & Plastic Surgery Surgical Gouge (FDA Code: GDH / 878.4800)

• General & Plastic Surgery Surgical Hook (FDA Code: GDG / 878.4800)

• General & Plastic Surgery Surgical Mallet (FDA Code: GFJ / 878.4800)

• General & Plastic Surgery Surgical Rasp (FDA Code: GAC / 878.4800)

• General & Plastic Surgery Surgical Spatula (FDA Code: GAF / 878.4800)

• General Surgical Scissors (FDA Code: LRW / 878.4800)

• Hand Splint and Component (FDA Code: ILH / 890.3475) A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.

• Hemostatic Clip Applier (FDA Code: HBT / 878.4800)

• Human Bone Rasps (FDA Code: HTR / 878.4800)

• Implantable Radiographic Marker (FDA Code: NEU / 878.4300) An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

• Infant Tongue Depressor (FDA Code: FMA / 880.6230) A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues.

• Instrument Surgical Guide (FDA Code: FZX / 878.4800)

• Internal Chin Prosthesis (FDA Code: FWP / 878.3550) A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.

• Internal Nose Prosthesis (FDA Code: FZE / 878.3680) A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.

• Junior Tongue Depressor (FDA Code: FMA / 880.6230)

• Lacrimal Dilator (FDA Code: HNW / 886.4350) A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

• Lacrimal Probes (FDA Code: HNL / 886.4350)

• Larynx Prosthesis (FDA Code: FWN / 874.3620)

• Ligature Carrier (FDA Code: GEJ / 878.4800)

• Ligature Carrier Set (FDA Code: GEJ / 878.4800)

• Locking Fracture System

• Malar Implants (FDA Code: LZK / 878.3550)

• Manual Saw & Accessories (FDA Code: GDR / 878.4800)

• Manual Surgical Chisel (FDA Code: FZO / 878.4800)

• Medical Rasps (FDA Code: HTR / 878.4800)

• Metal Vaginal Speculum (FDA Code: HDF / 884.4520) An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:

• Methyl Methacrylate for Cranioplasty (FDA Code: GXP / 882.5300) Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.

• Microsurgical Ear Hook (FDA Code: JYL / 874.4420)

• Mouth Gags (FDA Code: KBN / 874.4420)

• Nasal Chisel (FDA Code: KAN / 878.4800)

• Nasal Curette (FDA Code: KAP / 874.4420)

• Nasal Dilator (FDA Code: LWF / 874.3900) A nasal dilator is a device intended to provide temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or transient causes of nasal congestion associated with reduced nasal airflow. The device decreases airway resistance and increases nasal airflow. The external nasal dilator is constructed from one or more layers of material upon which a spring material is attached, with a skin adhesive applied to adhere to the skin of the nose; it acts with a pulling action to open the nares. The internal nasal dilator is constructed from metal or plastic and is placed inside the nostrils; it acts by pushing the nostrils open or by gently pressing on the columella.

• Nasal Knife (FDA Code: KAS / 874.4420)

• Nasal Rasps (FDA Code: KBA / 874.4420)

• Nasal Rongeur (FDA Code: KBB / 874.4420)

• Nasal Saw (FDA Code: KBC / 874.4420)

• Nasal Scissors (FDA Code: KBD / 874.4420)

• Nasal Scissors Straight (FDA Code: KBD / 874.4420)

• Non-Alterable Preformed Skull Bone Plate (FDA Code: GXN / 882.5330) A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.

• Non-Powered Goniometer (FDA Code: KQW / 888.1520) A nonpowered goniometer is a mechanical device intended for medical purposes to measure the range of motion of joints.