Gotham Medical LLC

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Contact: Steve Olsen - Regulatory Representative
Web: http://www.gothammedical.com
E-Mail:
Address: 725 River Road, Suite 32-254, Edgewater, New Jersey 07020, USA
Phone: +1-(201)-608-7169 | Map/Directions >>
 
 

Profile: Gotham Medical LLC designs, manufactures and markets ultimate orthopedic trauma & reconstruction products. We have different internal & external bone fixation solutions to fix the bone fractures and to correct the bone deformities as well. Our products include plates & screws, intramedullar nails and thoracic products. Our Hudson locking plate and screw family include next generation plates for the upper & lower extremity bones. Hudson 3.5 mm straight plates are indicated for the fixation of ulna/radius midshaft fractures. The plate and bone interface is minimized to reduce the constriction of the blood supply to the periosteum. The locking holes provide excellent stability on the osteoporotic bones, and severely comminuted fractures. Anatomic locking fibula plates are indicated for the treatment of fractures of the distal fibula. The plates are pre-shaped and provide excellent anatomic adaptation. Ultra low profile minimizes the disruption of the soft tissues. Our PectoLift bar system is designed to correct the pectus excavatum and carinatum deformities. Our bar system has rounded ended bars and low profiled stabilizers. Our Smart Correction computer assisted circular fixator is an excellent external fixator used by orthopedic surgeons to heal complex fractures and bone deformities.

32 Products/Services (Click for related suppliers)  
• AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE / 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.
• AC-Powered Surgical Instrument Motor (FDA Code: GEY / 878.4820)
• Bender (FDA Code: HXW / 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.
• Bending/Contouring Instrument (FDA Code: HXP / 888.4540)
• Bone Cap (FDA Code: JDT / 888.3000)
A bone cap is a mushroom-shaped device intended to be implanted made of either silicone elastomer or ultra-high molecular weight polyethylene. It is used to cover the severed end of a long bone, such as the humerus or tibia, to control bone overgrowth in juvenile amputees.
• Bone Mill (FDA Code: LYS / 888.4540)
• Bone Screw Starter (FDA Code: HWD / 888.4540)
• Bone Taps (FDA Code: HWX / 888.4540)
• Compression Instrument (FDA Code: HWN / 888.4540)
• Corkscrew (FDA Code: HWI / 888.4540)
• Disposable Surgical Instrument (FDA Code: KDC / 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.
• Disposable Surgical Instrument Kit (FDA Code: KDD / 878.4800)
• Femuroral Intramedullary Nails
• Fibula Plates
• General Surgical Manual Instrument (FDA Code: MDM / 878.4800)
• Instrument Surgical Guide (FDA Code: FZX / 878.4800)
• Medical Instrument Ultrasonic Cleaner (FDA Code: FLG / 880.6150)
An ultrasonic cleaner for medical instruments is a device intended for cleaning medical instruments by the emission of high frequency soundwaves.
• Orthopaedic Trauma & Clinical Therapies
• Orthopedic Burr (FDA Code: HTT / 888.4540)
• Orthopedic Cutting Instrument (FDA Code: HTZ / 878.4800)
• Orthopedic Knife (FDA Code: HTS / 888.4540)
• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 888.4540)
• Orthopedic Needle Holder (FDA Code: HXK / 888.4540)
• Orthopedic Spatula (FDA Code: HXR / 878.4800)
• Orthopedic Tape (FDA Code: HXT / 878.4800)
• Orthopedic Wire Passer (FDA Code: HXI / 888.4540)
• Screwdriver (FDA Code: HXX / 888.4540)
• Surgical Instrument Tray (FDA Code: FSM / 878.4800)
• Surgical Orthopedic Scissors (FDA Code: HRR / 888.4540)
• 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.
• Vertebroplasty Spinal Channeling Instrument (FDA Code: OCJ / 888.4540)
• Wire Cutters (FDA Code: HXZ / 888.4540)

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