Identity
- Trade Name
- CANNULATED SCREW SYSTEM FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Model / Reference
- 03-4005-46 FDA UDI
Identifiers
- Catalog Number
- 03-4005-46 FDA UDI
- Primary DI / UDI-DI
- 00840420102706 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Outer Diameter — 4 Millimeter FDA UDILength — 46 Millimeter FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile
The Cannulated Screw System is a highly effective, non-bioabsorbable orthopedic bone screw designed for internal fixation of fractures and interfragmentary stabilization of bones. Made from implant-grade metal, such as surgical steel or titanium alloy, this device provides strong and stable fixation with minimal tissue reaction. The cannulated design allows for precise thread placement and control during surgery.
Similar devices
Also classified as Orthopaedic bone screw, non-bioabsorbable, non-sterile.
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- Monster Screw System — Paragon 28 · Class II
- AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 75mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- APTUS — Medartis Inc. · Class II
- SMOOTH PEG — Biomet Orthopedics, Inc. · Class II
- AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 105mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- QWIX — Newdeal Sas · Class II
- Monster Screw System — Paragon 28 · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Wright Medical Technology, Inc.
Sources (1)
- FDA UDI 003aa436-2e37-4476-9d02-39bf4c3c1ac0 35 fields · synced Jul 10, 2026