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Ratcheting Comfort Cannulated T-Handle Small Hudson Adapter
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- RATCHETING COMFORT CANNULATED T-HANDLE SMALL HUDSON ADAPTER FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Model / Reference
- 0430-100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665034189 FDA UDI
- 510(k) Number
- K014185 FDA UDI
- FDA Product Code
- LXH FDA UDIHWC FDA UDI
- GMDN Term
- Surgical instrument handle, non-torque-limiting FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI888.3040 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 handle, non-torque-limiting
Ratcheting Comfort Cannulated T-Handle Small Hudson Adapter by Advanced Orthopaedic Solutions, Inc. — Class I — FDA UDI — listed in FDA GUDID
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Cleared under the same submission
K014185 also covers:
- 7.0mm TAP, SMALL HUDSON — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 100mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 110mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 115mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 120mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 125mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 130mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 135mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 140mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 145mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 150mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advanced Orthopaedic Solutions, Inc.
Sources (1)
- FDA UDI c1866e70-6c6e-4e94-8ad1-dc6b7b7ad4fb 34 fields · synced May 30, 2026