Profile: Synthes, Inc. develops market instruments, implants and biomaterials for the surgical fixation, correction and regeneration of the skeleton and its soft tissues. We develop & market instruments, implants & biomaterials for the surgical fixation, correction & regeneration of the human skeleton and its soft tissues. Our cranio-maxillofacial implants are used for the operative treatment of fractures of mandible, mid-face & skull. Our external fixator is used for external fracture stabilization at extremities with soft tissue injuries. The Trauma implants and instruments are used for the surgical treatment of fractures, deformities and tumour diseases of long bones (arms and legs), the shoulder, the hand, the foot and the pelvis and the portfolio contains plates, screws, cannulated screws, intramedullary nails, a comprehensive range. Our Bone void fillers are natural or synthetic materials which are placed into a bone defect during a surgical procedure to assist in bone regeneration. They fill a bone void or bridge a gap between bone segments and provide a three-dimensional scaffold for bone to grow on and also used for intended voids or gaps that are not intrinsic to the stability of the bone structure. They are used to augment internal or external fixation.
FDA Registration Number: 2939274
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• Surgical Stylet (FDA Code: GAH / 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. |
• Titanium Sternal Fixation System |
• Total Disc Replacements |
• Wrist Fracture Hardware |
• Wrist Implants, Wrist Fracture Hardware |