8011-20-01
by Zimmer, Inc.
8011-20-01 is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K001733 on 20 Jun 2000 (1 earlier submission) and listed in FDA GUDID since 31 Aug 2016 (UDI-DI 00889024376748), 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 | Number00889024376748 | Date31 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK001733 | Date20 Jun 2000 | StatusActive |
Official records
- AccessGUDID record 00889024376748
- FDA 510(k) database K001733
- FDA 510(k) database K800142
Across registries
- FDA 510(k) K001733 decided 20 Jun 2000 Active
- FDA GUDID UDI-DI 00889024376748 listed 31 Aug 2016 Listed
Recalls
-
- Terminated Z-1699-2009
The seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility.
Timeline
- Cleared FDA 510(k) K800142
- Cleared FDA 510(k) K001733
- Recall initiated FDA recalls Z-1699-2009
- Listed FDA GUDID 00889024376748
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Polymer orthopaedic cement restrictor, non-bioabsorbable
- Model / reference
- 8011-20-01
- Primary DI / UDI-DI
- 00889024376748
- FDA product code
- JDS, JDI, LZN
- GMDN term
- Polymer orthopaedic cement restrictor, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 888.3030, 888.3350, 878.3300
- GUDID distribution status
- In Commercial Distribution