Identity
- Trade Name
- AOS PROXIMAL HUMERAL NAIL 8mm x 20cm FDA UDI
- Generic Name
- Humerus intramedullary nail FDA UDI
- Model / Reference
- S1170-200 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665005554 FDA UDI
- 510(k) Number
- K090478 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Humerus intramedullary nail 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 PROXIMAL HUMERAL NAIL 8mm x 20cm 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 41fc6c4b-e340-4ffa-a747-72443b268c29 34 fields · synced May 31, 2026