Identity
- Trade Name
- AOS SCREW SPACER/COMPRESSION BOLT FDA UDI
- Generic Name
- Bone nail end-cap FDA UDI
- Model / Reference
- S1326 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665012576 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 Screw Spacer/Compression Bolt 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 75fdcfb5-957a-4f12-b354-46983a46eb15 34 fields · synced May 30, 2026