Identity
- Trade Name
- TRUMATCH FDA UDI
- Generic Name
- Custom-made orthopaedic/craniofacial surgical guide FDA UDI
- Device Name
- Titanium 3D Printed Guide, Bone harvesting FDA UDI
- Model / Reference
- SD980.028 FDA UDI
- Description
- Titanium 3D Printed Guide, Bone harvesting FDA UDI
Identifiers
- Catalog Number
- SD980.028 FDA UDI
- Primary DI / UDI-DI
- 05420060380747 FDA UDI
- 510(k) Number
- K243637 FDA UDI
- FDA Product Code
- DZJ FDA UDILLZ FDA UDI
- GMDN Term
- Custom-made orthopaedic/craniofacial surgical guide FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4120 FDA UDI892.2050 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Custom-made orthopaedic/craniofacial surgical guide
Trumatch by Materialise NV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Custom-made orthopaedic/craniofacial surgical guide.
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Cleared under the same submission
K243637 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 4bee996c-4326-4174-b9b9-4c6284dabcde 35 fields · synced Jun 8, 2026