00-5850-000-11
by Zimmer, Inc.
00-5850-000-11 is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K110940 on 1 Jul 2011 and listed in FDA GUDID since 17 Sep 2015 (UDI-DI 00889024195561), 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 | Number00889024195561 | Date17 Sep 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK110940 | Date1 Jul 2011 | StatusActive |
Official records
- AccessGUDID record 00889024195561
- FDA 510(k) database K110940
Across registries
- FDA 510(k) K110940 decided 1 Jul 2011 Active
- FDA GUDID UDI-DI 00889024195561 listed 17 Sep 2015 Listed
Timeline
- Cleared FDA 510(k) K110940
- Listed FDA GUDID 00889024195561
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Uncoated knee tibia prosthesis, metallic
- Model / Ref / Catalog
- 00-5850-000-11
- Primary DI / UDI-DI
- 00889024195561
- 510(k) Number
- FDA product code
- KRO, KWY, KWL, KWZ, LWJ, LPH, JDI, LZO
- GMDN term
- Uncoated knee tibia prosthesis, metallic
- Device class
- Class II
- Regulation number
- 888.3510, 888.3390, 888.3360, 888.3310, 888.3358, 888.3350, 888.3353
- GUDID distribution status
- In Commercial Distribution
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