Truliant 02-029-22-1320
Truliant 02-029-22-1320 is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K182346 on 26 Nov 2018 and listed in FDA GUDID since 18 Aug 2022 (UDI-DI 10885862532022), 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 | Number10885862532022 | Date18 Aug 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK182346 | Date26 Nov 2018 | StatusActive |
Official records
- AccessGUDID record 10885862532022
- FDA 510(k) database K182346
Across registries
- FDA 510(k) K182346 decided 26 Nov 2018 Active
- FDA GUDID UDI-DI 10885862532022 listed 18 Aug 2022 Listed
Timeline
- Cleared FDA 510(k) K182346
- Listed FDA GUDID 10885862532022
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Truliant
- Generic name
- Surgical drill guide, reusable
- Model / Ref / Catalog
- 02-029-22-1320
- Primary DI / UDI-DI
- 10885862532022
- 510(k) Number
- FDA product code
- MBH, JWH
- GMDN term
- Surgical drill 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
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