Identity
- Trade Name
- AOS END CAP, ANTEGRADE FEMORAL NAIL 0mm FDA UDI
- Generic Name
- Bone nail end-cap FDA UDI
- Model / Reference
- S1324 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665012569 FDA UDI
- 510(k) Number
- K123569 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Bone nail end-cap FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
AOS END CAP, ANTEGRADE FEMORAL NAIL 0mm by Advanced Orthopaedic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K123569 also covers:
- AOS ANTEGRADE FEMORAL NAIL, LEFT 10mm x 44cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS ANTEGRADE FEMORAL NAIL, LEFT 10mm x 46cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS ANTEGRADE FEMORAL NAIL, LEFT 13mm x 46cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS ANTEGRADE FEMORAL NAIL, LEFT 14mm x 32cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS ANTEGRADE FEMORAL NAIL, LEFT 14mm x 46cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS ANTEGRADE FEMORAL NAIL, LEFT 14mm x 48cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS ANTEGRADE FEMORAL NAIL, LEFT 9mm x 48cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS ANTEGRADE FEMORAL NAIL, RIGHT 10mm x 30cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS ANTEGRADE FEMORAL NAIL, RIGHT 10mm x 38cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS ANTEGRADE FEMORAL NAIL, RIGHT 10mm x 42cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS ANTEGRADE FEMORAL NAIL, RIGHT 11mm x 30cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS ANTEGRADE FEMORAL NAIL, RIGHT 11mm x 34cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
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
- Advanced Orthopaedic Solutions, Inc.
Sources (1)
- FDA UDI 01a69483-8f5a-46fc-888f-676def7e6793 34 fields · synced May 30, 2026