Identity
- Trade Name
- 4.0mm CORTICAL TAP (AO STYLE) FDA UDI
- Generic Name
- Bone tap, single-use, non-sterile FDA UDI
- Model / Reference
- 4029 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665030037 FDA UDI
- 510(k) Number
- K152732 FDA UDI
- FDA Product Code
- HWC FDA UDIHRS FDA UDI
- GMDN Term
- Bone tap, single-use, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.3030 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone tap, single-use, non-sterile
4.0mm CORTICAL TAP (AO STYLE) 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
K152732 also covers:
- 2.7mm Calibrated Drill — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS Cannulated Drill, 2.75mm, Ankle Plate — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
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- Anterolateral Distal Tibia Plate, Right, Long, 23-Hole — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- Anterolateral Distal Tibia Plate, Right, Short, 15-Hole — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 36mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 40mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 46mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 50mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- Cannulated Headless Compression Screw, 1/4 Threaded, 3.5mm x 20mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- Cannulated Headless Compression Screw, 1/4 Threaded, 3.5mm x 34mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- Cannulated Headless Compression Screw, 1/4 Threaded, 3.5mm x 65mm — 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 8f41d18b-5432-45ee-9886-ead3dd9993fb 34 fields · synced May 30, 2026