J2 E0016329-2
J2 E0016329-2 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K113482 on 27 Feb 2012 and listed in FDA GUDID since 11 Jan 2019 (UDI-DI 00885556737439), 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 | Number00885556737439 | Date11 Jan 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK113482 | Date27 Feb 2012 | StatusActive |
Official records
- AccessGUDID record 00885556737439
- FDA 510(k) database K113482
Across registries
- FDA 510(k) K113482 decided 27 Feb 2012 Active
- FDA GUDID UDI-DI 00885556737439 listed 11 Jan 2019 Listed
Timeline
- Cleared FDA 510(k) K113482
- Listed FDA GUDID 00885556737439
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- J2
- Generic name
- Knee tibia prosthesis trial, reusable
- Model / Ref / Catalog
- E0016329-2
- Primary DI / UDI-DI
- 00885556737439
- 510(k) Number
- FDA product code
- JWH
- GMDN term
- Knee tibia prosthesis trial, reusable
- Device class
- Class II
- Regulation number
- 888.3560
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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