NexGen SSI004643
by Zimmer, Inc.
NexGen SSI004643 is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K152494 on 25 Nov 2015 and listed in FDA GUDID since 23 Aug 2018 (UDI-DI 00889024518261), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00889024518261 | Date23 Aug 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK152494 | Date25 Nov 2015 | StatusActive |
Official records
- AccessGUDID record 00889024518261
- FDA 510(k) database K152494
Across registries
- FDA 510(k) K152494 decided 25 Nov 2015 Active
- FDA GUDID UDI-DI 00889024518261 listed 23 Aug 2018 Listed
Recalls
-
- Terminated Z-0630-2019
Screw is missing from the package
Timeline
- Cleared FDA 510(k) K152494
- Listed FDA GUDID 00889024518261
- Recall initiated FDA recalls Z-0630-2019
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- NexGen
- Generic name
- Knee tibia prosthesis trial, reusable
- Model / Ref / Catalog
- SSI004643
- Primary DI / UDI-DI
- 00889024518261
- 510(k) Number
- FDA product code
- KRO, JWH
- GMDN term
- Knee tibia prosthesis trial, reusable
- Device class
- Class II
- Regulation number
- 888.3510, 888.3560
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- Size
- Height — 5 Millimeter
Similar devices in this category
Other devices filed under Knee tibia prosthesis trial, reusable.