PunchTac DFX0027R
PunchTac DFX0027R is a Class II device made by Dunamis Medical LLC, cleared under FDA 510(k) K160996 on 6 Jul 2016 and listed in FDA GUDID since 9 Nov 2018 (UDI-DI 00854629006635), active as of 22 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 | Number00854629006635 | Date9 Nov 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK160996 | Date6 Jul 2016 | StatusActive |
Official records
- AccessGUDID record 00854629006635
- FDA 510(k) database K160996
Across registries
- FDA 510(k) K160996 decided 6 Jul 2016 Active
- FDA GUDID UDI-DI 00854629006635 listed 9 Nov 2018 Listed
Timeline
- Cleared FDA 510(k) K160996
- Listed FDA GUDID 00854629006635
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- PunchTac
- Generic name
- Orthopaedic bone screw, non-bioabsorbable, sterile
- Model / Ref / Catalog
- DFX0027R
- Primary DI / UDI-DI
- 00854629006635
- 510(k) Number
- FDA product code
- MBI
- GMDN term
- Orthopaedic bone screw, non-bioabsorbable, sterile
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
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