Cytoflex Mesh M4-400
Cytoflex Mesh M4-400 (C02-4401) is a Class II device made by Unicare Biomedical, Inc., cleared under FDA 510(k) K021511 on 6 Aug 2002 and listed in FDA GUDID since 23 Nov 2016 (UDI-DI D767C0244010), 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 | NumberD767C0244010 | Date23 Nov 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK021511 | Date6 Aug 2002 | StatusActive |
Official records
- FDA 510(k) database K021511
Across registries
- FDA 510(k) K021511 decided 6 Aug 2002 Active
- FDA GUDID UDI-DI D767C0244010 listed 23 Nov 2016 Listed
Timeline
- Cleared FDA 510(k) K021511
- Listed FDA GUDID D767C0244010
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cytoflex Mesh
- Generic name
- Dental bone matrix implant, metallic
- Model / Ref / Catalog
- M4-400, C02-4401
- Primary DI / UDI-DI
- D767C0244010
- 510(k) Number
- FDA product code
- JEY
- GMDN term
- Dental bone matrix implant, metallic
- Device class
- Class II
- Regulation number
- 872.4760
- GUDID distribution status
- In Commercial Distribution
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