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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• 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-Surgical 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.

• Nose And Throat Ear Bur (FDA Code: EQJ / 874.4140) An ear, nose, and throat bur is a device consisting of an interchangeable drill bit that is intended for use in an ear, nose, and throat electric or pneumatic surgical drill (874.4250) for incising or removing bone in the ear, nose, or throat area. The bur consists of a carbide cutting tip on a metal shank or a coating of diamond on a metal shank. The device is used in mastoid surgery, frontal sinus surgery, and surgery of the facial nerves.

• Nose And Throat Ear Cement (FDA Code: NEA / 872.3275) Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

• Ophthalmic Retractor (FDA Code: HNI / 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.

• Oral Screw (FDA Code: KBW / 874.4420)

• Oral Surgery, Extraction Tray

• Oral Surgery, Hard Tissue Biopsy Tray

• Orbital Retractors

• 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.

• Orthopedic Needle Holder (FDA Code: HXK / 888.4540)

• Orthopedic Osteotome (FDA Code: HWM / 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.

• Orthopedic Wire Passer (FDA Code: HXI / 888.4540)

• Osteotomy Tray

• Plastic Surgery, Cleft Lip Tray

• Plastic Surgery, Cleft Palate Tray

• Plastic Surgery, Instrument Tray

• Plastic Surgery, Rhinoplasty Tray

• Polytetrafluoroethylene Vitreous Carbon Material for Maxillofacial Reconstruction (FDA Code: KKY / 878.3500) A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.

• Powered Heating Unit (FDA Code: IRQ / 890.5950) A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.

• Ratcheting Driver Handles

• Reusable Aspiration and Injection Needle (FDA Code: GDM / 878.4800)

• Reusable Vein Stripper (FDA Code: GAI / 878.4800)

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

• Scalpel Blade (FDA Code: GES / 878.4800)

• Scalpel Handle (FDA Code: GDZ / 878.4800)

• Screw Cartridges

• Screw Delivery Systems

• Screwdriver (FDA Code: HXX / 888.4540)

• Simple Powered Trephines & Accessories (FDA Code: HBE / 882.4310) Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.

• Skull Punch (FDA Code: GXJ / 882.4750) A skull punch is a device used to punch holes through a patient's skull to allow fixation of cranioplasty plates or bone flaps by wire or other means.

• Smooth Fixation Pin (FDA Code: HTY / 888.3040) A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

• Soft Ear Speculum (FDA Code: EPY / 878.1800) A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories.

• Soft Tissue Non-Biodegradable Fixation Fastener (FDA Code: MBI / 888.3040)

• Sterile ENT Wire Cutting Scissors (FDA Code: JYA / 874.3540) A prosthesis modification instrument for ossicular replacement surgery is a device intended for use by a surgeon to construct ossicular replacements. This generic type of device includes the ear, nose, and throat cutting block; wire crimper, wire bending die; wire closure forceps; piston cutting jib; gelfoamTMpunch; wire cutting scissors; and ossicular finger vise.

• Sternal Closure Systems

• Suction Catheter and Tip (FDA Code: JOL / 880.6740) A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

• Surgical Cutter (FDA Code: FZT / 878.4800)

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

• Surgical Knife (FDA Code: EMF / 878.4800)

• Surgical Needle Guide (FDA Code: GDF / 878.4800)

• Surgical Pliers (FDA Code: HTC / 878.4800)

• Surgical Punch (FDA Code: LRY / 878.4800)

• Surgical Retractor (FDA Code: GAD / 878.4800)

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

• Surgical Stripper (FDA Code: HRT / 888.4540)

• Surgical Stylet (FDA Code: GAH / 878.4800)

• Surgical Trays (FDA Code: LRP / 878.4800)

• Surgical Trays (FDA Code: LRP / 878.4800)

• Synthetic Absorbable Suture (FDA Code: GAN / 878.4830) An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.