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Sign in to claim this brandSYNTHES (U.S.A.) LP
US
Last updated May 24, 2026
What SYNTHES (U.S.A.) LP makes
The company manufactures spinal interbody fusion cages made from polymeric materials, including modular cervical and lumbar total disc prostheses designed to replace damaged intervertebral discs. Their portfolio also includes non-bioabsorbable orthopaedic fixation plates for spinal and long-bone stabilization, as well as external fixation systems for single-use orthopaedic applications. Reusable instrument trays and implant racks are provided for surgical workflow organization, and trial implants are available for research and clinical testing purposes.
The devices fall under FDA classification as Class I, Class II, and Class III, reflecting varying levels of regulatory oversight based on risk. All listed products are registered in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations. The manufacturer operates within the United States, adhering to domestic regulatory requirements for each device category.
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 SYNTHES (U.S.A.) LP primarily manufacture?
SYNTHES (U.S.A.) LP specializes in spinal and orthopaedic devices, including polymeric spinal interbody fusion cages designed for intervertebral disc replacement. Their portfolio also covers modular cervical and lumbar total disc prostheses, non-bioabsorbable orthopaedic fixation plates for spinal and long-bone stabilization, and external orthopaedic fixation systems for single-use applications. Additionally, they provide reusable surgical instrument trays and implant racks to support surgical workflows, as well as trial implants for research and clinical testing.
Where is SYNTHES (U.S.A.) LP based, and how does this affect its regulatory compliance?
SYNTHES (U.S.A.) LP is based in the United States, which means its devices must comply with U.S. regulatory requirements, including FDA regulations. Since the company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, this ensures traceability and adherence to domestic medical device standards. The classification of their devices—Class I, II, or III—determines the level of regulatory oversight, with higher-risk devices requiring more stringent evaluation.
Which regulatory registries list SYNTHES (U.S.A.) LP’s devices, and why is this important?
SYNTHES (U.S.A.) LP’s devices are registered in the FDA’s Unique Device Identifier (UDI) database. This registry is critical because it provides transparency and traceability for healthcare providers, regulators, and patients. The UDI system helps track devices throughout their lifecycle, ensuring compliance with U.S. medical device regulations and facilitating recalls or post-market surveillance if needed.
How are SYNTHES (U.S.A.) LP’s devices classified under FDA regulations, and what does this mean?
SYNTHES (U.S.A.) LP’s devices are classified as Class I, Class II, or Class III under FDA regulations, depending on their risk level. Class I devices pose the lowest risk (e.g., some reusable instrument trays) and generally require only general controls. Class II devices (e.g., certain spinal implants) involve special controls to mitigate moderate risks, while Class III devices (e.g., high-risk prostheses) require premarket approval due to their significant risk potential. The classification determines the regulatory pathway and scrutiny each device undergoes.
What kinds of spinal and orthopaedic solutions does SYNTHES (U.S.A.) LP offer for clinical trials?
SYNTHES (U.S.A.) LP provides spinal implant trials, including experimental or prototype devices for research and clinical testing. These trial implants allow surgeons and researchers to evaluate new technologies before broader commercialization. The company’s offerings in this area support innovation in spinal fusion cages, disc prostheses, and fixation systems, helping advance orthopaedic treatments through evidence-based development.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- xx.xx
- —
- —
- [email protected]
- Phone
- +1(800)255-2500
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 832637081
Catalogue (1390)
Page 22 of 28| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SynFix-LR | 08.802.003S | FDA UDI | Class II | Unknown |
| MatrixMANDIBLE | SD449.501 | FDA UDI | Class II | Active |
| Lc-Dcp | 690.319 | FDA UDI | Class I | Unknown |
| Axon | 405.508 | FDA UDI | Class II | Unknown |
| Uss | 499.640 | FDA UDI | Class II | Unknown |
| Opal | 08.803.116 | FDA UDI | Class II | Active |
| Lc-Dcp | 440.515 | FDA UDI | Class II | Unknown |
| Atb | 449.132 | FDA UDI | Class II | Unknown |
| Click'X | 498.505 | FDA UDI | Class II | Unknown |
| Atb | 449.102 | FDA UDI | Class II | Unknown |
| ProDisc-C | 09.820.047S | FDA UDI | Class III | Active |
| Click'X | 498.581 | FDA UDI | Class II | Unknown |
| Click'X | 04.606.057 | FDA UDI | Class II | Unknown |
| Atb | 449.062 | FDA UDI | Class II | Unknown |
| Vertebral Spacer-Pr | 08.803.004 | FDA UDI | Class II | Unknown |
| Epoca | E5113-10XL | FDA UDI | Class I | Unknown |
| Lc-Dcp | 440.525 | FDA UDI | Class II | Unknown |
| Click'X | 485.980 | FDA UDI | Class II | Unknown |
| Lcp | 04.110.451 | FDA UDI | Class II | Unknown |
| SynFix-LR | 03.802.013 | FDA UDI | Class I | Active |
| Lc-Dcp | 690.318 | FDA UDI | Class I | Unknown |
| Aclp | 450.286 | FDA UDI | Class II | Unknown |
| Click'X | 487.075 | FDA UDI | Class II | Unknown |
| Click'X | 485.952 | FDA UDI | Class II | Unknown |
| Atb | 449.135 | FDA UDI | Class II | Unknown |
| Axon | 404.538 | FDA UDI | Class II | Unknown |
| PlusDrive | SD514.221 | FDA UDI | Class I | Unknown |
| Lcp | 238.709 | FDA UDI | Class II | Active |
| Lc-Dcp | 225.007 | FDA UDI | Class II | Unknown |
| Vertebral Spacer-Tr | 305.032 | FDA UDI | Class I | Active |
| Dcp | 224.12 | FDA UDI | Class II | Unknown |
| Click'X | 499.086 | FDA UDI | Class II | Unknown |
| Lcp | 04.110.430 | FDA UDI | Class II | Unknown |
| Vertebral Spacer-Ar | 889.906 | FDA UDI | Class II | Active |
| Epoca | E5113-10L | FDA UDI | Class I | Unknown |
| SynFix-LR | 03.802.002 | FDA UDI | Class I | Active |
| Maxframe | 1100012-01 | FDA UDI | Class II | Active |
| Uss | 499.660 | FDA UDI | Class II | Unknown |
| Lc-Dcp | 224.60 | FDA UDI | Class II | Active |
| Click'X | 499.412 | FDA UDI | Class II | Unknown |
| Lcp | 04.110.350 | FDA UDI | Class II | Unknown |
| Click'X | 487.153 | FDA UDI | Class II | Unknown |
| Click'X | 485.966 | FDA UDI | Class II | Unknown |
| Atb | 03.601.144 | FDA UDI | Class I | Active |
| Lc-Dcp | 440.531 | FDA UDI | Class II | Unknown |
| Matrix | 04.633.665 | FDA UDI | Class II | Unknown |
| Lcp | 238.710S | FDA UDI | Class II | Unknown |
| Lc-Dcp | 426.66 | FDA UDI | Class II | Unknown |
| Lcp | 04.110.340 | FDA UDI | Class II | Unknown |
| Axon | 04.200.623 | FDA UDI | Class II | Unknown |
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