02-029-19-2000
02-029-19-2000 is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K181794 on 28 Sep 2018 (1 earlier submission) and listed in FDA GUDID since 28 Jul 2022 (UDI-DI 10885862523617), 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 | Number10885862523617 | Date28 Jul 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK181794 | Date28 Sep 2018 | StatusActive |
Official records
- AccessGUDID record 10885862523617
- FDA 510(k) database K181794
- FDA 510(k) database K170240
Across registries
- FDA 510(k) K181794 decided 28 Sep 2018 Active
- FDA GUDID UDI-DI 10885862523617 listed 28 Jul 2022 Listed
Timeline
- Cleared FDA 510(k) K170240
- Cleared FDA 510(k) K181794
- Listed FDA GUDID 10885862523617
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Fluted surgical drill bit, reusable
- Model / Ref / Catalog
- 02-029-19-2000
- Primary DI / UDI-DI
- 10885862523617
- FDA product code
- MBH, JWH
- GMDN term
- Fluted surgical drill bit, 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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