Identity
- Trade Name
- TCP FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Model / Reference
- 07-310 FDA UDI
Identifiers
- Catalog Number
- 07-310 FDA UDI
- Primary DI / UDI-DI
- 00840420117441 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Length — 10 Millimeter FDA UDIOuter Diameter — 2.5 Millimeter FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile
WRIGHT MEDICAL TECHNOLOGY, INC. introduces the TCP (Orthopaedic Bone Screw), a non-bioabsorbable, non-sterile device designed for orthopedic fixation of bones in internal fractures. This device features a threaded rod with a slotted head and is used to provide direct interfragmentary stabilization or hold plates or nails to bone.
Similar devices
Also classified as Orthopaedic bone screw, non-bioabsorbable, non-sterile.
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- 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 884fff8a-0584-41bb-a856-f95e2cecea77 35 fields · synced Jul 11, 2026