Identity
- Trade Name
- TiMesh FDA UDI
- Generic Name
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
- Device Name
- PLATE 015-255 SMALL X FDA UDI
- Model / Reference
- 015-255 FDA UDI
- Description
- PLATE 015-255 SMALL X FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169620476 FDA UDI
- 510(k) Number
- K062348 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Craniofacial fixation plate, non-bioabsorbable, non-customized 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
Yes
FDA UDI
Implantable
Yes
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 Conditional FDA UDI
Category: Craniofacial fixation plate, non-bioabsorbable, non-customized
TiMesh by Medtronic PS Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Craniofacial fixation plate, non-bioabsorbable, non-customized.
- LEVEL ONE CMF — KLS-Martin L.P. · Class II
- Leforte System Bone Plate — Jeil Medical Corporation · Class II
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- MCI - Medical Concept Innovation, Inc. — MCI MEDICAL CONCEPT INNOVATION INC. · Class II
- TraumaOne SYSTEM — BIOMET MICROFIXATION, INC · Class II
- Leforte System Bone Plate — Jeil Medical Corporation · Class II
- AccuPlate® Patient-Specific Plate — Medcad · Class II
- Leforte Neuro System Bone Plate — Jeil Medical Corporation · Class II
Cleared under the same submission
K062348 also covers:
- TiMesh — Medtronic PS Medical
- TiMesh — Medtronic PS Medical
- TiMesh — Medtronic PS Medical
- TiMesh — Medtronic PS Medical
- TiMesh — Medtronic PS Medical
- TiMesh — Medtronic PS Medical
- TiMesh — Medtronic PS Medical
- TiMesh — Medtronic PS Medical
- TiMesh — Medtronic PS Medical
- TiMesh — Medtronic PS Medical
- TiMesh — Medtronic PS Medical
- TiMesh — Medtronic PS Medical
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
- Medtronic PS Medical
Sources (1)
- FDA UDI 77e4171a-f8ba-4342-afda-6d86ece3d480 35 fields · synced May 30, 2026