Identity
- Trade Name
- AOS RETROGRADE FEMORAL NAIL 12mm x 40cm FDA UDI
- Generic Name
- Femur nail, non-sterile FDA UDI
- Model / Reference
- 1342-040 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665018769 FDA UDI
- 510(k) Number
- K132005 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Femur nail, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Femur nail, non-sterile
AOS RETROGRADE FEMORAL NAIL 12mm x 40cm by Advanced Orthopaedic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Femur nail, non-sterile.
- Flow-Nail™ — Flow-Fx, LLC · Class II
- OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- AIM™FEMORAL NAIL — Biomet Orthopedics, Inc. · Class II
- Syntec Femoral Nail System — Syntec Scientific Corp. · Class II
- A.R.T.™FEMORAL NAIL — Biomet Orthopedics, Inc. · Class II
- Syntec Femoral Nail System — Syntec Scientific Corp. · Class II
- Syntec Femoral Nail System — Syntec Scientific Corp. · Class II
- Syntec Femoral Nail System — Syntec Scientific Corp. · Class II
Cleared under the same submission
K132005 also covers:
- AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 140mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 30mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CANCELLOUS SCREW, PARTIAL THREAD 6.0mm x 115mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CANCELLOUS SCREW, PARTIAL THREAD 6.0mm x 120mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CANCELLOUS SCREW, PARTIAL THREAD 6.0mm x 45mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CANCELLOUS SCREW, PARTIAL THREAD 6.0mm x 50mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CORTICAL SCREW 5.0mm x 105mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CORTICAL SCREW 5.0mm x 40mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CORTICAL SCREW 5.0mm x 70mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CORTICAL SCREW 5.0mm x 80mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CORTICAL SCREW 5.0mm x 90mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 55mm — 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 a7dc62b8-d35d-472b-9bda-8bf23d76758f 33 fields · synced Jun 6, 2026