Identity
- Trade Name
- TruMatch FDA UDI
- Generic Name
- Craniofacial fixation plate kit, non-bioabsorbable FDA UDI
- Device Name
- TRUMATCH Orthognathics - Basic Maxillary Surgical Kit, without Planning FDA UDI
- Model / Reference
- SD980.008 FDA UDI
- Description
- TRUMATCH Orthognathics - Basic Maxillary Surgical Kit, without Planning FDA UDI
Identifiers
- Catalog Number
- SD980.008 FDA UDI
- Primary DI / UDI-DI
- 05420060380082 FDA UDI
- 510(k) Number
- K170272 FDA UDI
- FDA Product Code
- JEY FDA UDI
- GMDN Term
- Craniofacial fixation plate kit, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4760 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Craniofacial fixation plate kit, non-bioabsorbable
TruMatch by Materialise NV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Craniofacial fixation plate kit, non-bioabsorbable.
- OsteoMed — Osteomed Corp. · Class II
- Bone Fixation Screw Kit — Jeil Medical Corporation · Class II
- OsteoMed — Osteomed Corp. · Class II
- OsteoMed — Osteomed Corp. · Class II
- OsteoMed — Osteomed Corp. · Class II
- OsteoMed — Osteomed Corp. · Class II
- OsteoMed — Osteomed Corp. · Class II
- VERUM System Surgical Instrument — Jeil Medical Corporation · Class I
Cleared under the same submission
K170272 also covers:
- TRUMATCH — Materialise NV
- TRUMATCH — Materialise NV
- TruMatch — Materialise NV
- TruMatch — Materialise NV
- TruMatch — Materialise NV
- TruMatch — Materialise NV
- TruMatch — Materialise NV
- TruMatch — Materialise NV
- TruMatch — Materialise NV
- TruMatch — Materialise NV
- TruMatch — Materialise NV
- TruMatch — Materialise NV
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
- Materialise NV
Sources (1)
- FDA UDI 87b4b807-eabe-4581-91a7-9808b5b8eb83 35 fields · synced May 30, 2026