Identity
- Trade Name
- EXOFIX FDA UDI
- Generic Name
- Vertebral bone filler, non-bioabsorbable FDA UDI
- Model / Reference
- T040323 FDA UDI
Identifiers
- Catalog Number
- T040323 FDA UDI
- Primary DI / UDI-DI
- 03760177042391 FDA UDI
- FDA Product Code
- NDN FDA UDI
- GMDN Term
- Vertebral bone filler, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3027 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Vertebral bone filler, non-bioabsorbable
Exofix by Teknimed — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Vertebral bone filler, non-bioabsorbable.
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- SINPLUS S — Sintea Plustek, LLC · Class II
- SpinePlex — Stryker Corp. · Class II
- VertaPlex — Stryker Corp. · Class II
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
- Teknimed
Sources (1)
- FDA UDI f654caa5-87c4-4942-b715-5764cf1c4e22 34 fields · synced Jun 1, 2026