Identity
- Trade Name
- TEMPORARY EXTERNAL FIXATION KIT FDA UDI
- Generic Name
- Surgical instrument/implant rack FDA UDI
- Model / Reference
- 9908-001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665024135 FDA UDI
- 510(k) Number
- K080408 FDA UDI
- FDA Product Code
- KTT FDA UDI
- GMDN Term
- Surgical instrument/implant rack FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument/implant rack
Temporary External Fixation Kit by Advanced Orthopaedic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K080408 also covers:
- AOS CLAMP 5.0mm PIN x 9.5mm ROD — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CLAMP 9.5mm ROD x 9.5mm ROD — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS MULTI-PIN CLAMP ASSEMBLY — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS THREADED CENTER PIN 6.0mm x 280mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS THREADED HALF PIN (AO STYLE) 5.0mm x 180mm x 20mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS THREADED HALF PIN (AO STYLE) 5.0mm x 180mm x 30mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS THREADED HALF PIN (AO STYLE) 5.0mm x 180mm x 40mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS THREADED HALF PIN (AO STYLE) 5.0mm x 180mm x 50mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS THREADED HALF PIN (AO STYLE) 5.0mm x 180mm x 60mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS THREADED HALF PIN (AO STYLE) 5.0mm x 180mm x 70mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS THREADED HALF PIN (AO STYLE) 5.0mm x 220mm x 20mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS THREADED HALF PIN (AO STYLE) 5.0mm x 220mm x 30mm — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advanced Orthopaedic Solutions, Inc.
Sources (1)
- FDA UDI a9571bf4-3ff3-4893-895a-7c391248cba6 34 fields · synced Jun 6, 2026