Profile: Synthes GmbH develops, produces and markets instruments, implants & biomaterials for the surgical fixation, correction & regeneration of the skeleton & its soft tissues. Trauma implants and instruments are used for the surgical treatment of fractures, deformities & tumor diseases of long bones (arms & legs), the shoulder, the hand, the foot & the pelvis. The portfolio contains plates, screws, cannulated screws, intramedullary nails, a comprehensive range of external fixators, products for the hip & condyles and a wide selection of instruments. The dynamic hip system (DHS) is the appropriate solution for proximal femoral fractures. It is modular and consists of DHS blade or DHS screw, LCP plates or standard plates & locking trochanter stabilizing plate. Our spine portfolio covers products for the treatment of degenerative instabilities, fractures, tumors, and deformities, offering a full range of solutions for the cervical, thoracic & lumbar spine.

FDA Registration Number: 8030965
US Agent: Karen Parker / Synthes Gmbh / Synthes Produktions Gmbh
Phone: +1-(610)-719-6567  E-Mail:

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• Surgical Pliers (FDA Code: HTC / 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.

• Surgical Punch (FDA Code: LRY / 878.4800)

• Surgical Retractor (FDA Code: GAD / 878.4800)

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

• Suture Retention Device (FDA Code: KGS / 878.4930) A suture retention device is a device, such as a retention bridge, a surgical button, or a suture bolster, intended to aid wound healing by distributing suture tension over a larger area in the patient.

• Tamps (FDA Code: HXG / 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.

• Templates (FDA Code: HWT / 888.4800) A template for clinical use is a device that consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.

• Threaded Fixation Pin (FDA Code: JDW / 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.

• Vertebroplasty (Does Not Contain Cement) Injector (FDA Code: OAR / 888.4200) A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (888.3027) into surgical sites.

• Wire Cutters (FDA Code: HXZ / 888.4540)

• Wire Holding Forceps (FDA Code: HYA / 878.4800)

• Wire Twisters (FDA Code: HXS / 888.4540)

• Wrench (FDA Code: HXC / 888.4540)