Djo Surgical 344-11-711
Djo Surgical 344-11-711 is a Class II device made by Encore Medical LP, cleared under FDA 510(k) K170573 on 31 May 2017 and listed in FDA GUDID since 1 Jun 2017 (UDI-DI 00190446215288), active as of 8 Nov 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 | Number00190446215288 | Date1 Jun 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK170573 | Date31 May 2017 | StatusActive |
Official records
- AccessGUDID record 00190446215288
- FDA 510(k) database K170573
Across registries
- FDA 510(k) K170573 decided 31 May 2017 Active
- FDA GUDID UDI-DI 00190446215288 listed 1 Jun 2017 Listed
Timeline
- Cleared FDA 510(k) K170573
- Listed FDA GUDID 00190446215288
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Djo Surgical
- Generic name
- Tibial insert
- Model / reference
- 344-11-711
- Primary DI / UDI-DI
- 00190446215288
- 510(k) Number
- FDA product code
- JWH, OIY
- GMDN term
- Tibial insert
- Device class
- Class II
- Regulation number
- 888.3560
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Tibial insert.