Identity
- Trade Name
- SynMesh FDA UDI
- Generic Name
- Vertebral body prosthesis FDA UDI
- Device Name
- SYNMESH® 12MM DIA 150MM HEIGHT/CONTOURED (TI) FDA UDI
- Model / Reference
- 495.635 FDA UDI
- Description
- SYNMESH® 12MM DIA 150MM HEIGHT/CONTOURED (TI) FDA UDI
Identifiers
- Catalog Number
- 495635 FDA UDI
- Primary DI / UDI-DI
- 10705034786384 FDA UDI
- 510(k) Number
- K041389 FDA UDI
- FDA Product Code
- MQP FDA UDI
- GMDN Term
- Vertebral body prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Vertebral body prosthesis
SynMesh by Synthes — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Synthes
Sources (1)
- FDA UDI 9f870307-03f7-473e-87ff-181baa05c2c6 36 fields · synced May 30, 2026