Truliant 02-029-13-8030
Truliant 02-029-13-8030 is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K181794 on 28 Sep 2018 (2 earlier submissions) and listed in FDA GUDID since 18 Aug 2022 (UDI-DI 10885862523082), active as of 23 Oct 2026. 2 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
2 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10885862523082 | Date18 Aug 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK181794 | Date28 Sep 2018 | StatusActive |
Official records
- AccessGUDID record 10885862523082
- FDA 510(k) database K181794
- FDA 510(k) database K171045
- FDA 510(k) database K170240
Across registries
- FDA 510(k) K181794 decided 28 Sep 2018 Active
- FDA GUDID UDI-DI 10885862523082 listed 18 Aug 2022 Listed
Recalls
-
- Ongoing Z-0585-2024
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
-
- Ongoing Z-0023-2022
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Timeline
- Cleared FDA 510(k) K170240
- Cleared FDA 510(k) K171045
- Cleared FDA 510(k) K181794
- Recall initiated FDA recalls Z-0023-2022
- Listed FDA GUDID 10885862523082
- Recall initiated FDA recalls Z-0585-2024
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Truliant
- Generic name
- Osteotomy guide, reusable
- Model / Ref / Catalog
- 02-029-13-8030
- Primary DI / UDI-DI
- 10885862523082
- FDA product code
- MBH, JWH
- GMDN term
- Osteotomy guide, reusable
- Device class
- Class II
- Regulation number
- 888.3565, 888.3560
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization