Tutogen Medical Gmbh

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Contact: Eric Schaber - National Sales Manager
Web: http://www.tutogen.de
E-Mail:
Address: Industriestrasse 6, Neunkirchen a Brand 91077, Germany
Phone: +49-(9134)-99 88 - 5 00 | Fax: +49-(9134)-99 88 - 5 19 | Map/Directions >>

Profile: Tutogen Medical Gmbh develops pharmaceutical and medical devices. Our allogeneic bone grafts and xenogeneic origin of orthopedic & trauma products are used successfully worldwide. Our tissue sparing Tutoplast® process preserves the natural collagen-mineral composite graft, and thus retains its biomechanical properties.

The company was founded in 1985, has revenues of USD 5-10 Million, has ~120 employees and is ISO 9001, CE certified.

FDA Registration Number: 3002924436
US Agent: Elizabeth Deigl / Rti Surgical, Inc.
Phone: +1-(386)-418-8888 Fax: +1-(386)-518-6596 E-Mail:

37 Products/Services (Click for related suppliers)

• Allogeneic Cancellous

• Bone Clamp (FDA Code: HXD / 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.

• Bone Fixation Screw (FDA Code: HWC / 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.

• Bone Fixation Staple (FDA Code: JDR / 888.3030)

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

• Bone Rasps (FDA Code: HTR / 878.4800)

• Bone Taps (FDA Code: HWX / 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.

• Calcium Compound Bone Void Filler (FDA Code: MQV / 888.3045)

A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

• Cannulated Drill Bit

• Cement Mixing Equipment (FDA Code: JDZ / 888.4210)

A cement mixer for clinical use is a device consisting of a container intended for use in mixing bone cement (888.3027).

• 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.

• Drill Bit (FDA Code: HTW / 888.4540)

• Drill Bits & Bone Taps

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

• General & Plastic Surgery Surgical Spatula (FDA Code: GAF / 878.4800)

• Human Bone Rasps (FDA Code: HTR / 878.4800)

• Instrument Surgical Guide (FDA Code: FZX / 878.4800)

• Laparoscopic Ligature

• Lyophilized Human Dura Mater (FDA Code: LEM / 882.5975)

Human dura mater is human pachymeninx tissue intended to repair defects in human dura mater.

• Medical Rasps (FDA Code: HTR / 878.4800)

• Non-absorbable Suture Anchors

• Non-Absorbable Sutures (FDA Code: GAO / 878.4495)

• Non-Implanted Hemodialysis Catheters (FDA Code: MPB / 876.5540)

A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.

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

• Osteoinduction Bone Void Filler (FDA Code: MBP / 888.3045)

• Polybutester Suture

• Reamer (FDA Code: HTO / 888.4540)

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

• Screwdriver (FDA Code: HXX / 888.4540)

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

• Stainless Steel Ligature Wire

• Stainless Steel Suture

• Stainless Steel Suture Wire

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

• Surgical Mesh (FDA Code: FTM / 878.3300)

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

• Tamps (FDA Code: HXG / 888.4540)

• Vessel Guard/Cover (FDA Code: MFX / 870.3470)

An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.

• Xenogeneic Cancellous