Identity
- Trade Name
- TITAN 3-D Wedge System FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- TITAN, Evans Wedge Inserter FDA UDI
- Model / Reference
- P03-905-9001 FDA UDI
- Description
- TITAN, Evans Wedge Inserter FDA UDI
Identifiers
- Catalog Number
- P03-905-9001 FDA UDI
- Primary DI / UDI-DI
- 00889795020024 FDA UDI
- 510(k) Number
- K162241 FDA UDI
- FDA Product Code
- PLF FDA UDI
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Orthopaedic inorganic implant inserter/extractor, reusable
TITAN 3-D Wedge System by Paragon 28 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic inorganic implant inserter/extractor, reusable.
- Omnia Medical Golden Spike — Omnia Medical · Class I
- Calibrate — ALPHATEC SPINE, INC. · Class II
- PAR 5 RING-LOC — Biomet Orthopedics, Inc. · Class I
- Made-To-Order — TORNIER, INC. · Class I
- Vu ePOD™ — SeaSpine Orthopedics Corporation · Class II
- Mariner MCT — SeaSpine Orthopedics Corporation · Class II
- PEEK Corpectomy — Nuvasive, Inc. · Class II
- TIMBERLINE LATERAL FUSION SYSTEM — BIOMET SPINE LLC · Class II
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 952e098e-f6fe-4c43-9365-b1e6ed624d0b 35 fields · synced Jun 8, 2026