Identity
- Trade Name
- TITAN 3-D Wedge System FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- TITAN, Cotton Precision Screw Guide, Right FDA UDI
- Model / Reference
- P03-950-0003 FDA UDI
- Description
- TITAN, Cotton Precision Screw Guide, Right FDA UDI
Identifiers
- Catalog Number
- P03-950-0003 FDA UDI
- Primary DI / UDI-DI
- 00889795020093 FDA UDI
- 510(k) Number
- K162241 FDA UDI
- FDA Product Code
- PLF FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
TITAN 3-D Wedge System by Paragon 28 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K162241 also covers:
- TITAN 3-D Wedge System — Paragon 28
- TITAN 3-D Wedge System — Paragon 28
- TITAN 3-D Wedge System — Paragon 28
- TITAN 3-D Wedge System — Paragon 28
- TITAN 3-D Wedge System — Paragon 28
- TITAN 3-D Wedge System — Paragon 28
- TITAN 3-D Wedge System — Paragon 28
- TITAN 3-D Wedge System — Paragon 28
- TITAN 3-D Wedge System — Paragon 28
- TITAN 3-D Wedge System — Paragon 28
- TITAN 3-D Wedge System — Paragon 28
- TITAN 3-D Wedge System — Paragon 28
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Paragon 28
Sources (1)
- FDA UDI 4212d351-4127-4f14-b5e4-64440e1bde08 35 fields · synced May 31, 2026