00-5210-009-06
by Zimmer, Inc.
00-5210-009-06 is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K141697 on 18 Sep 2014 and listed in FDA GUDID since 2 Jul 2016 (UDI-DI 00889024081130), 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 | Number00889024081130 | Date2 Jul 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK141697 | Date18 Sep 2014 | StatusActive |
Official records
- AccessGUDID record 00889024081130
- FDA 510(k) database K141697
Across registries
- FDA 510(k) K141697 decided 18 Sep 2014 Active
- FDA GUDID UDI-DI 00889024081130 listed 2 Jul 2016 Listed
Timeline
- Cleared FDA 510(k) K141697
- Listed FDA GUDID 00889024081130
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Model / Ref / Catalog
- 00-5210-009-06
- Primary DI / UDI-DI
- 00889024081130
- 510(k) Number
- FDA product code
- KTT
- GMDN term
- Orthopaedic prosthesis implantation positioning instrument, reusable
- Device class
- Class II
- Regulation number
- 888.3030
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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