Identity
- Trade Name
- MatrixNEURO FDA UDI
- Generic Name
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
- Device Name
- TI MATRIXNEURO BURR HOLE COVER FOR LARGE SHUNT/17MM FDA UDI
- Model / Reference
- SD422.002 FDA UDI
- Description
- TI MATRIXNEURO BURR HOLE COVER FOR LARGE SHUNT/17MM FDA UDI
Identifiers
- Catalog Number
- SD422002 FDA UDI
- Primary DI / UDI-DI
- 10887587003252 FDA UDI
- 510(k) Number
- K042365 FDA UDI
- FDA Product Code
- JEY FDA UDI
- GMDN Term
- Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4760 FDA UDI
- Commercial Distribution
- Not 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
MatrixNEURO by Synthes (u.s.a.) Lp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K042365 also covers:
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 |
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Manufacturer
- Manufacturer
- Synthes (u.s.a.) Lp
Sources (1)
- FDA UDI 55650b44-d631-4962-86ed-2f2515aec20b 37 fields · synced May 30, 2026