Identity
- Trade Name
- AOS CLAVICLE INTRAMEDULLARY DEVICE 2.7mm x 100mm FDA UDI
- Generic Name
- Internal orthopaedic fixation system, cerclage wire/cable, non-sterile FDA UDI
- Model / Reference
- 1335-100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665023787 FDA UDI
- 510(k) Number
- K143204 FDA UDI
- FDA Product Code
- JDW FDA UDIHSB FDA UDI
- GMDN Term
- Internal orthopaedic fixation system, cerclage wire/cable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.3020 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: Internal orthopaedic fixation system, cerclage wire/cable, non-sterile
AOS CLAVICLE INTRAMEDULLARY DEVICE 2.7mm x 100mm by Advanced Orthopaedic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Internal orthopaedic fixation system, cerclage wire/cable, non-sterile.
- Kirschner wire — Zimmer, Inc. · Class I
- Accord — Smith & Nephew, Inc. · Class II
- Kirschner wire with trocar tip — Zimmer, Inc. · Class II
- Accord — Smith & Nephew, Inc. · Class II
- TSF — Smith & Nephew, Inc. · Class II
- Accord — Smith & Nephew, Inc. · Class II
- Kirschner wire — Zimmer, Inc. · Class I
- Cerclage Button 3.5T — Miami Device Solutions · Class II
Cleared under the same submission
K143204 also covers:
- AOS CLAVICLE INTRAMEDULLARY DEVICE 2.7mm x 110mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CLAVICLE INTRAMEDULLARY DEVICE 2.7mm x 120mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CLAVICLE INTRAMEDULLARY DEVICE 2.7mm x 80mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CLAVICLE INTRAMEDULLARY DEVICE 2.7mm x 90mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CLAVICLE INTRAMEDULLARY DEVICE 3.5mm x 100mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CLAVICLE INTRAMEDULLARY DEVICE 3.5mm x 110mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CLAVICLE INTRAMEDULLARY DEVICE 3.5mm x 120mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CLAVICLE INTRAMEDULLARY DEVICE 3.5mm x 80mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CLAVICLE INTRAMEDULLARY DEVICE 3.5mm x 90mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CLAVICLE INTRAMEDULLARY DEVICE 4.0mm x 100mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CLAVICLE INTRAMEDULLARY DEVICE 4.0mm x 110mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CLAVICLE INTRAMEDULLARY DEVICE 4.0mm x 120mm — 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 6b80e39a-e695-43fa-a87b-954d092ec0d1 33 fields · synced May 30, 2026