Identity
- Trade Name
- CANNULATED STRAIGHT AWL W/ T-HANDLE FDA UDI
- Generic Name
- Bone awl, reusable FDA UDI
- Model / Reference
- 0218-100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665032314 FDA UDI
- 510(k) Number
- K050241 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Bone awl, reusable 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
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: Bone awl, reusable
Cannulated Straight Awl W/ T-Handle 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
K050241 also covers:
- 10.5mm CANNULATED ENTRY REAMER — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- 2.5mm HEX SCREWDRIVER — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- 3.5mm HEX SCREWDRIVER — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS SCREW 5.0mm x 20.0mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS SCREW 5.0mm x 22.5mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS SCREW 5.0mm x 32.5mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS SCREW 5.0mm x 37.5mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS SCREW 5.0mm x 40.0mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS SCREW 5.0mm x 42.5mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS SCREW 5.0mm x 45.0mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS SCREW 5.0mm x 47.5mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS SCREW 5.0mm x 50.0mm — 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 5f8ebf01-2fdb-4ad4-8c89-0694efb07bf2 34 fields · synced May 31, 2026