MatrixMANDIBLE 04.503.429.01
by Synthes
MatrixMANDIBLE 04.503.429.01 (0450342901) is a Class II device made by Synthes, cleared under FDA 510(k) K201944 on 10 Sep 2020 and listed in FDA GUDID since 28 Oct 2020 (UDI-DI 10887587075907), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10887587075907 | Date28 Oct 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK201944 | Date10 Sep 2020 | StatusActive |
Official records
- AccessGUDID record 10887587075907
- FDA 510(k) database K201944
Across registries
- FDA 510(k) K201944 decided 10 Sep 2020 Active
- FDA GUDID UDI-DI 10887587075907 listed 28 Oct 2020 Listed
Timeline
- Cleared FDA 510(k) K201944
- Listed FDA GUDID 10887587075907
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MatrixMANDIBLE
- Generic name
- Craniofacial bone screw, non-bioabsorbable
- Model / Ref / Catalog
- 04.503.429.01, 0450342901
- Primary DI / UDI-DI
- 10887587075907
- 510(k) Number
- FDA product code
- JEY
- GMDN term
- Craniofacial bone screw, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 872.4760
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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