Identity
- Trade Name
- SMALL BONE EXTERNAL FIXATION SYSTEM CASE FDA UDI
- Generic Name
- Surgical instrument/implant rack FDA UDI
- Model / Reference
- 9933-100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665032185 FDA UDI
- 510(k) Number
- K141912 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
Small Bone External Fixation System Case 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
K141912 also covers:
- AOS CLAMP 5mm PIN x 5mm ROD — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS HEX BOLT — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS HEX POST BENT — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS HEX POST STRAIGHT — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS MULTI-PIN CLAMP ASSEMBLY CENTER — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS MULTI-PIN CLAMP EXTENSION ONE PIN — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS NUT — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS PARALLEL FIXATION NUT — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS THREADED HALF PIN (AO STYLE) 2.0mm x 100mm x 10mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS THREADED HALF PIN (AO STYLE) 2.0mm x 100mm x 15mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS THREADED HALF PIN (AO STYLE) 2.0mm x 100mm x 20mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS THREADED HALF PIN (AO STYLE) 2.0mm x 100mm x 25mm — 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 ac2ff748-3cda-4024-ae34-dc9cbe7d12b9 34 fields · synced May 30, 2026