Identity
- Trade Name
- Alphatec Solus FDA UDI
- Generic Name
- Spinal implant trial FDA UDI
- Device Name
- SOLUS LUMBAR TRIAL, MEDIUM, 16mm, 7° LORDOTIC, BODY FDA UDI
- Model / Reference
- 25940-116 FDA UDI
- Description
- SOLUS LUMBAR TRIAL, MEDIUM, 16mm, 7° LORDOTIC, BODY FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840967190341 FDA UDI
- 510(k) Number
- K123993 FDA UDI
- FDA Product Code
- OVD FDA UDI
- GMDN Term
- Spinal implant trial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Alphatec Solus by Alphatec Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K123993 also covers:
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
- Alphatec Spine, Inc.
Sources (1)
- FDA UDI 344cb1bd-5506-425e-8709-bc827a2a4301 36 fields · synced Jun 8, 2026