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Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 36mm
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 36mm FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Model / Reference
- 8081-036 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665025200 FDA UDI
- 510(k) Number
- K152732 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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: Orthopaedic bone screw, non-bioabsorbable, non-sterile
Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 36mm by Advanced Orthopaedic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Orthopaedic bone screw, non-bioabsorbable, non-sterile.
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- QWIX — Newdeal Sas · Class II
- Monster Screw System — Paragon 28 · Class II
- TMS SYSTEM — BIOMET MICROFIXATION, INC · Class II
- Flow-Screw™ — Flow-Fx, LLC · Class II
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.
- AOS DRILL, Ø2.8mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- 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 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.
- Cannulated Headless Compression Screw, 1/4 Threaded, 3.5mm x 70mm — 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 47f2be4a-f007-484c-bfab-1e03ba47e2a1 33 fields · synced Jun 1, 2026