PDS Plates ZFP8
by Ethicon Inc.
PDS Plates ZFP8 is a Class II device made by Ethicon Inc., cleared under FDA 510(k) K092590 on 17 Feb 2010 and listed in FDA GUDID since 14 Jun 2017 (UDI-DI 10705031132535), 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 | Number10705031132535 | Date14 Jun 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK092590 | Date17 Feb 2010 | StatusActive |
Official records
- AccessGUDID record 10705031132535
- FDA 510(k) database K092590
Across registries
- FDA 510(k) K092590 decided 17 Feb 2010 Active
- FDA GUDID UDI-DI 10705031132535 listed 14 Jun 2017 Listed
Timeline
- Cleared FDA 510(k) K092590
- Listed FDA GUDID 10705031132535
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- PDS Plates
- Generic name
- Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
- Model / Ref / Catalog
- ZFP8
- Primary DI / UDI-DI
- 10705031132535
- 510(k) Number
- FDA product code
- NHB
- GMDN term
- Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
- Device class
- Class II
- Regulation number
- 874.3620
- GUDID distribution status
- In Commercial Distribution
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