Djo Surgical 425-99-013S
by Djo, LLC
Djo Surgical 425-99-013S is a Class II device made by Djo, LLC, cleared under FDA 510(k) K120241 on 24 Feb 2012 and listed in FDA GUDID since 5 Jul 2016 (UDI-DI 00888912079006), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00888912079006 | Date5 Jul 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK120241 | Date24 Feb 2012 | StatusActive |
Official records
- AccessGUDID record 00888912079006
- FDA 510(k) database K120241
Across registries
- FDA 510(k) K120241 decided 24 Feb 2012 Active
- FDA GUDID UDI-DI 00888912079006 listed 5 Jul 2016 Listed
Recalls
-
- Ongoing Z-1692-2020
The retaining ring on the neck trials has a potential to fail interoperatively.
Timeline
- Cleared FDA 510(k) K120241
- Listed FDA GUDID 00888912079006
- Recall initiated FDA recalls Z-1692-2020
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Djo Surgical
- Generic name
- Coated hip femur prosthesis, modular
- Model / reference
- 425-99-013S
- Primary DI / UDI-DI
- 00888912079006
- 510(k) Number
- FDA product code
- LZO, LPH
- GMDN term
- Coated hip femur prosthesis, modular
- Device class
- Class II
- Regulation number
- 888.3353, 888.3358
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Coated hip femur prosthesis, modular.