4815-22
by Zimmer, Inc.
4815-22 (00-4815-022-00) is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K140508 on 14 Aug 2014 and listed in FDA GUDID since 16 Oct 2015 (UDI-DI 00889024069848), 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 | Number00889024069848 | Date16 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK140508 | Date14 Aug 2014 | StatusActive |
Official records
- AccessGUDID record 00889024069848
- FDA 510(k) database K140508
Across registries
- FDA 510(k) K140508 decided 14 Aug 2014 Active
- FDA GUDID UDI-DI 00889024069848 listed 16 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K140508
- Listed FDA GUDID 00889024069848
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Orthopaedic bone screw (non-sliding)
- Model / Ref / Catalog
- 4815-22, 00-4815-022-00
- Primary DI / UDI-DI
- 00889024069848
- 510(k) Number
- FDA product code
- HWC, HTN, HRS
- GMDN term
- Orthopaedic bone screw (non-sliding)
- Device class
- Class II
- Regulation number
- 888.3040, 888.3030
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- Size
- Length — 22 Millimeter
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