Identity
- Trade Name
- AOS FRACTURE REDUCTION SCREW HUMERAL NAIL FDA UDI
- Generic Name
- Bone nail end-cap FDA UDI
- Model / Reference
- S1175 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665005745 FDA UDI
- 510(k) Number
- K090478 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 Fracture Reduction Screw Humeral Nail by Advanced Orthopaedic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K090478 also covers:
- AOS CORTICAL SCREW 3.5mm x 10.0mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS Drill, AO Style, 2.9mm x 100mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS HUMERAL NAIL 7.0mm x 22.5cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS HUMERAL NAIL 7.0mm x 25cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS HUMERAL NAIL 7.0mm x 27.5cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS HUMERAL NAIL 7.0mm x 32.5cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS HUMERAL NAIL 8.0mm x 20cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS HUMERAL NAIL 8.0mm x 22.5cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS HUMERAL NAIL 8.0mm x 25cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS HUMERAL NAIL 8.0mm x 27.5cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS HUMERAL NAIL 8.0mm x 30cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS HUMERAL NAIL 9.0mm x 22.5cm — 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 3acd8a5e-aa4c-4499-b51c-2ecf6c24dc72 34 fields · synced Jun 7, 2026