Tedan Surgical Innovations, LLc

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Contact: Daniel Fishman
Web: http://www.tedansurgical.com
E-Mail:
Address: 11333, Chimney Rock Road, Suite 180, Houston, Texas 77035, USA
Phone: +1-(713)-726-0886/877-726-0886 | Fax: +1-(713)-726-0886 | Map/Directions >>

Profile: 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 provides bone penetration. It is available both in sterile and non-sterile packaging. Our Phantom LS™ sure lock contains adjustable blade holders, retractor body and front & side loading retractor handles.

FDA Registration Number: 3005726885

34 Products/Services (Click for related suppliers)

• Calipers (FDA Code: KTZ / 888.4150)

A caliper for clinical use is a compass-like device intended for use in measuring the thickness or diameter of a part of the body or the distance between two body surfaces, such as for measuring an excised skeletal specimen to determine the proper replacement size of a prosthesis.

• Curettes (FDA Code: HTF / 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.

• Depth Gauge (FDA Code: HTJ / 888.4300)

A depth gauge for clinical use is a measuring device intended for various medical purposes, such as to determine the proper length of screws for fastening the ends of a fractured bone.

• ENT Elevator (FDA Code: KAD / 874.4420)

• ENT Forceps (FDA Code: KAE / 874.4420)

• Fiberoptic Retractor (FDA Code: FDG / 876.4530)

A gastroenterology-urology fiberoptic retractor is a device that consists of a mechanical retractor with a fiberoptic light system that is used to illuminate deep surgical sites.

• Flexible Depth Gauge (FDA Code: HTJ / 888.4300)

• Forceps (FDA Code: HTD / 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 Hook (FDA Code: GDG / 878.4800)

• General Surgical Manual Instrument (FDA Code: MDM / 878.4800)

• General use Surgical Curettes (FDA Code: FZS / 878.4800)

• Nasal Curette (FDA Code: KAP / 874.4420)

• Nasal Rongeur (FDA Code: KBB / 874.4420)

• Non-Powered Surgical Instrument (FDA Code: HAO / 882.4535)

A nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It includes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps, gouges, hooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade holders, blade breakers, probes, etc.

• Non-Self-Retaining Retractor (FDA Code: FGN / 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.

• Orthopedic Elevator (FDA Code: HTE / 878.4800)

• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 888.4540)

An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

• Pin Surgical Driver (FDA Code: GFC / 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.

• Retractors

• Rib Rongeurs (FDA Code: HTX / 888.4540)

• Ruler and Caliper (FDA Code: FTY / 878.4800)

• Screwdriver (FDA Code: HXX / 888.4540)

• Self-Retaining Retractors (FDA Code: FFO / 876.4730)

• Small Depth Gauge (FDA Code: HTJ / 888.4300)

• Surgical Bit (FDA Code: GFG / 878.4820)

• Surgical Curette (FDA Code: FZS / 878.4800)

• Surgical Instrument Tray (FDA Code: FSM / 878.4800)

• Surgical Retractor (FDA Code: GAD / 878.4800)

• Surgical Retractor Systems (FDA Code: GAD / 878.4800)

• Surgical Trays (FDA Code: LRP / 878.4800)

• Table Operating Room Accessories (FDA Code: FWZ / 878.4950)

A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.