Identity
- Trade Name
- TALOS®-C FDA UDI
- Generic Name
- Spinal implant trial FDA UDI
- Model / Reference
- 500-071212-07-A FDA UDI
Identifiers
- Primary DI / UDI-DI
- B16750007121207A0 FDA UDI
- FDA Product Code
- ODP FDA UDI
- GMDN Term
- Spinal implant trial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Spinal implant trial
Talos®-C by Meditech Spine, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Spinal implant trial.
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- IdentiTi — ALPHATEC SPINE, INC. · Class II
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- IdentiTi — ALPHATEC SPINE, INC. · Class II
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Cleared under the same submission
K142345 also covers:
- TALOS®-C — MEDITECH SPINE, LLC
- TALOS®-C — MEDITECH SPINE, LLC
- TALOS®-C — MEDITECH SPINE, LLC
- TALOS®-C — MEDITECH SPINE, LLC
- TALOS®-C — MEDITECH SPINE, LLC
- TALOS®-C — MEDITECH SPINE, LLC
- TALOS®-C — MEDITECH SPINE, LLC
- TALOS®-C — MEDITECH SPINE, LLC
- TALOS®-C — MEDITECH SPINE, LLC
- TALOS®-C — MEDITECH SPINE, LLC
- TALOS®-C — MEDITECH SPINE, LLC
- TALOS®-C — MEDITECH SPINE, LLC
K150788 also covers:
- TALOS® IBF — MEDITECH SPINE, LLC
- TALOS® IBF — MEDITECH SPINE, LLC
- TALOS® IBF — MEDITECH SPINE, LLC
- TALOS® IBF — MEDITECH SPINE, LLC
- TALOS® IBF — MEDITECH SPINE, LLC
- TALOS® IBF — MEDITECH SPINE, LLC
- TALOS® IBF — MEDITECH SPINE, LLC
- TALOS® IBF — MEDITECH SPINE, LLC
- TALOS® IBF — MEDITECH SPINE, LLC
- TALOS® IBF — MEDITECH SPINE, LLC
- TALOS® IBF — MEDITECH SPINE, LLC
- TALOS® IBF — MEDITECH SPINE, LLC
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
- Meditech Spine, Llc
Sources (1)
- FDA UDI 92f46b59-1e0e-45c1-8cbb-6f1e1353cdb4 33 fields · synced May 31, 2026