HammerTech CD-01-6029
HammerTech CD-01-6029 is a Class II device made by Fusion Orthopedics, LLC, cleared under FDA 510(k) K182684 on 23 Nov 2018 and listed in FDA GUDID since 22 Apr 2019 (UDI-DI 00819034027170), 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 | Number00819034027170 | Date22 Apr 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK182684 | Date23 Nov 2018 | StatusActive |
Official records
- AccessGUDID record 00819034027170
- FDA 510(k) database K182684
Across registries
- FDA 510(k) K182684 decided 23 Nov 2018 Active
- FDA GUDID UDI-DI 00819034027170 listed 22 Apr 2019 Listed
Timeline
- Cleared FDA 510(k) K182684
- Listed FDA GUDID 00819034027170
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- HammerTech
- Generic name
- Cannulated surgical drill bit, single-use, non-sterile
- Model / Ref / Catalog
- CD-01-6029
- Primary DI / UDI-DI
- 00819034027170
- 510(k) Number
- FDA product code
- HWC
- GMDN term
- Cannulated surgical drill bit, single-use, non-sterile
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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