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Sign in to claim this brandWhat Synthes makes
The company manufactures orthopaedic fixation hardware, including non-bioabsorbable plates and screws for bone stabilization, as well as spinal implants such as trial devices, interbody fusion cages, and spinal screws and plates. It also produces craniofacial fixation plates for non-customized facial reconstruction and surgical instrument racks for organizing implants and tools. The portfolio includes specific devices like RapidSorb, MatrixMIDFACE, MatrixMANDIBLE, and various models of the DHS and LCP systems.
These 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 company operates from the United States, adhering to applicable U.S. regulatory requirements for medical devices.
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 manufacture?
Synthes specializes in orthopaedic and craniofacial fixation devices. Its portfolio includes non-bioabsorbable orthopaedic fixation plates and screws for bone stabilization, spinal implants like trial devices and interbody fusion cages, spinal screws and plates, and craniofacial fixation plates for non-customized facial reconstruction. The company also produces surgical instrument racks to organize implants and tools.
Where is Synthes based, and how does that affect its regulatory compliance?
Synthes is based in the United States, which means its devices must comply with U.S. regulatory requirements, including those set by the FDA. Since the company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, they are subject to U.S. medical device regulations, including classification under FDA’s Class I and Class II categories.
Which regulatory registries list Synthes’ devices?
Synthes’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers and regulators.
How are Synthes’ devices classified under FDA regulations?
Synthes’ devices fall under FDA’s Class I and Class II categories. Class I generally includes low-risk devices requiring general controls, while Class II involves special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, risk level, and potential impact on patient health.
What does it mean for Synthes’ devices to be listed in the FDA’s UDI database?
Listing in the FDA’s UDI database means each of Synthes’ devices has a unique identifier assigned to it, improving traceability and reducing medical errors. This system helps healthcare providers quickly verify device details, such as manufacturer, model, and batch information, ensuring proper use and compliance with regulatory standards.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (12063)
Page 16 of 242| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| RapidSorb | 852.263.01S | FDA UDI | Class II | Active |
| Volt | 04.527.344 | FDA UDI | Class II | Active |
| MatrixRIB | 04.501.214.01 | FDA UDI | Class II | Active |
| MatrixMANDIBLE | 03.503.057 | FDA UDI | Class I | Active |
| SynMesh | 495.366 | FDA UDI | Class II | Active |
| SYNFIX Evolution | 08.815.254S | FDA UDI | Class II | Active |
| Va-Lcp | 04.117.103S | FDA UDI | Class II | Active |
| Volt | 04.535.890S | FDA UDI | Class II | Active |
| Lcp | 249.697 | FDA UDI | Class II | Active |
| Va-Lcp | 02.211.260S | FDA UDI | Class II | Active |
| Opal | 08.803.131 | FDA UDI | Class II | Active |
| Volt | 04.420.120TS | FDA UDI | Class II | Active |
| Matrix | 04.632.680 | FDA UDI | Class II | Active |
| Kincise | 200002100 | FDA UDI | Class I | Active |
| Volt | 02.538.507 | FDA UDI | Class II | Active |
| Dcs | 338.47 | FDA UDI | Class I | Active |
| Dhs | 280.315S | FDA UDI | Class II | Active |
| Uss | 499.297 | FDA UDI | Class II | Active |
| Matrix | 04.616.930 | FDA UDI | Class II | Active |
| Tfn-Advance | 04.037.224S | FDA UDI | Class II | Active |
| Dhs | 281.012 | FDA UDI | Class II | Active |
| Lc-Dcp | 242.221 | FDA UDI | Class II | Active |
| MatrixNEURO | 04.503.083 | FDA UDI | Class II | Active |
| Lcp | 441.282 | FDA UDI | Class II | Active |
| Zero-P VA | 04.647.127S | FDA UDI | Class II | Active |
| Acis | 08.843.410 | FDA UDI | Class II | Active |
| Alif | 03.808.117 | FDA UDI | Class I | Active |
| Synex | 495.325 | FDA UDI | Class II | Active |
| Acf | 389.087 | FDA UDI | Class I | Active |
| Volt | 02.535.665TS | FDA UDI | Class II | Active |
| Volt | 02.535.350 | FDA UDI | Class II | Active |
| Lcp | 241.171 | FDA UDI | Class II | Active |
| SynMesh | 495.362 | FDA UDI | Class II | Active |
| Volt | 04.527.324TS | FDA UDI | Class II | Active |
| Volt | 02.535.870S | FDA UDI | Class II | Active |
| Volt | 02.527.124 | FDA UDI | Class II | Active |
| Lcp | 02.001.326S | FDA UDI | Class II | Active |
| SYNFIX Evolution | 03.835.156 | FDA UDI | Class I | Active |
| SYNFIX Evolution | 03.835.375 | FDA UDI | Class I | Active |
| Volt | 04.527.190 | FDA UDI | Class II | Active |
| Volt | 02.424.150 | FDA UDI | Class II | Active |
| SynCage | 08.825.305S | FDA UDI | Class II | Active |
| Zero-P VA | 03.647.737 | FDA UDI | Class II | Active |
| Vertebral Spacer-Cr | 889.924 | FDA UDI | Class II | Active |
| Volt | 02.527.309 | FDA UDI | Class II | Active |
| Volt | 02.420.348 | FDA UDI | Class II | Active |
| Volt | 04.535.150 | FDA UDI | Class II | Active |
| Lcp | 236.510 | FDA UDI | Class II | Active |
| Cslp | 487.342 | FDA UDI | Class II | Active |
| Cslp | 350.357 | FDA UDI | Class I | Active |
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