HammerTech HT-2X-3406
HammerTech HT-2X-3406 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 17 May 2024 (UDI-DI 00840124511941), 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 | Number00840124511941 | Date17 May 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK182684 | Date23 Nov 2018 | StatusActive |
Official records
- AccessGUDID record 00840124511941
- FDA 510(k) database K182684
Across registries
- FDA 510(k) K182684 decided 23 Nov 2018 Active
- FDA GUDID UDI-DI 00840124511941 listed 17 May 2024 Listed
Timeline
- Cleared FDA 510(k) K182684
- Listed FDA GUDID 00840124511941
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- HammerTech
- Generic name
- Implantable orthopaedic/craniofacial device connection screw
- Model / reference
- HT-2X-3406
- Primary DI / UDI-DI
- 00840124511941
- 510(k) Number
- FDA product code
- HWC
- GMDN term
- Implantable orthopaedic/craniofacial device connection screw
- 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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