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Sign in to claim this brandSIGNUS Medizintechnik GmbH
US
Last updated May 24, 2026
What SIGNUS Medizintechnik GmbH makes
SIGNUS Medizintechnik GmbH manufactures reusable orthopaedic surgical kits and spinal fixation hardware, including non-bioabsorbable bone screws, metallic and polymeric interbody fusion cages, internal fixation rods, connectors, hooks, and spinal plates. Their portfolio also includes spinal fixation systems designed for internal stabilization, such as the COSY, DIPLOMAT, and RABEA series, as well as specialized implants like the TASMIN R and TETRIS II 4°.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does SIGNUS Medizintechnik GmbH primarily manufacture?
SIGNUS Medizintechnik GmbH specializes in orthopaedic surgical procedure kits and spinal fixation hardware. Their portfolio includes reusable non-medicated kits, as well as devices like non-bioabsorbable bone screws, metallic and polymeric spinal interbody fusion cages, internal spinal fixation rods, connectors, hooks, and non-bioabsorbable spinal plates. These products are designed for spinal stabilization and fusion procedures.
Where is SIGNUS Medizintechnik GmbH based?
SIGNUS Medizintechnik GmbH operates from the United States. The company’s headquarters and manufacturing operations are located within the country, though specific regional offices or production sites may vary.
Which regulatory registries list SIGNUS Medizintechnik GmbH’s devices?
SIGNUS Medizintechnik GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for devices authorized under FDA regulations, including those classified under Class I and Class II categories.
How are SIGNUS Medizintechnik GmbH’s devices classified under FDA regulations?
SIGNUS Medizintechnik GmbH’s devices fall into two primary FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and clinical benefits.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- signus.com
- —
- —
- [email protected]
- Phone
- +49602391660
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 344203948
Catalogue (5251)
Page 2 of 106| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tetris Ii 8° | Lumbar cage, angled | FDA UDI | Class II | Active |
| Tasmin R | Graft loading platform | FDA UDI | Class I | Active |
| Monopoly | Pedicle screw, monoaxial | FDA UDI | Class II | Active |
| Monopoly | Pedicle screw, polyaxial | FDA UDI | Class II | Active |
| Rabea 0° | Cervical cage, straight | FDA UDI | Class II | Active |
| Nubic | Rasp | FDA UDI | Class I | Active |
| Cosy | Tulips cross connector, incl. set screws/retaining nuts | FDA UDI | Class II | Active |
| MONOPOLY Def. | Pedicle hook | FDA UDI | Class II | Active |
| Diplomat | Awl cannulated | FDA UDI | Class I | Active |
| Diplomat | Phantom rod | FDA UDI | Class I | Active |
| Tetris | Distractor | FDA UDI | Class I | Active |
| Conklusion | Tap | FDA UDI | Class I | Active |
| Cylox St | Variable angle screw, self tapping, 2-thread | FDA UDI | Class II | Active |
| Monopoly | Screw plate | FDA UDI | Class I | Active |
| Tetris R St 0° | Lumbar cage, straight | FDA UDI | Class II | Active |
| Diplomat | Pedicle screw, fenestrated, monoaxial | FDA UDI | Class II | Active |
| Diplomat | Rack, set screws | FDA UDI | Class I | Active |
| Diplomat | Pedicle screw, fenestrated, monoaxial, incl. set screw | FDA UDI | Class II | Active |
| Nubic | Cervical cage | FDA UDI | Class II | Active |
| Tosca | Awl | FDA UDI | Class I | Active |
| Diplomat Ft | Pedicle screw w/o tulip, fenestrated, polyaxial | FDA UDI | Class II | Active |
| Cylox St | Trial | FDA UDI | Class I | Active |
| Diplomat | Valve | FDA UDI | Class I | Active |
| Diplomat | Rack, screws | FDA UDI | Class I | Active |
| Diplomat Ft | Pedicle screw w/o tulip, fenestrated, polyaxial | FDA UDI | Class II | Active |
| Monopoly | Screwdriver monoaxial | FDA UDI | Class I | Active |
| Tasmin R | Trial | FDA UDI | Class I | Active |
| Tetris St 16° | Lumbar cage, angled | FDA UDI | Class II | Active |
| Diplomat | Pedicle screw w/o tulip, polyaxial | FDA UDI | Class II | Active |
| Tetris R St 6° | Lumbar cage, angled | FDA UDI | Class II | Active |
| Cosy | Hook offset connector, left | FDA UDI | Class II | Active |
| Diplomat | Rod, straight | FDA UDI | Class II | Active |
| Cylox St 0° | Cervical cage, straight | FDA UDI | Class II | Active |
| Monopoly | Pedicle screw, reduction, polyaxial | FDA UDI | Class II | Active |
| Tetris St 0° | Lumbar cage, straight | FDA UDI | Class II | Active |
| Instrument | Pedicle sensor | FDA UDI | Class I | Active |
| Tasmin R | Inserter, T-handle | FDA UDI | Class I | Active |
| Diplomat | Rod, straight | FDA UDI | Class II | Active |
| Tetris St | Trial | FDA UDI | Class I | Active |
| Diplomat Ft | Pedicle screw w/o tulip, fenestrated, polyaxial | FDA UDI | Class II | Active |
| Cosy | Screw with tulip, polyaxial | FDA UDI | Class II | Active |
| Tasmin R | Trial | FDA UDI | Class I | Active |
| Cosy | Screw with tulip, angled, polyaxial, self drilling | FDA UDI | Class II | Active |
| Ascot | Drill | FDA UDI | Class I | Active |
| Tetris R St 0° | Lumbar cage, straight | FDA UDI | Class II | Active |
| Cerccess | Tray, instruments | FDA UDI | Class I | Active |
| Tetris St 12° | Lumbar cage, angled | FDA UDI | Class II | Active |
| Cylox St | Trial | FDA UDI | Class I | Active |
| Diplomat | Parallel connector OC | FDA UDI | Class II | Active |
| Diplomat | Pedicle screw w/o tulip, fenestrated, polyaxial | FDA UDI | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Signus Medizintechnik Gmbh ALZENAU Bavaria · DE FEI 1000615957