Simpact Tri-Fin 152-112
Simpact Tri-Fin 152-112 is a Class II device made by Life Spine, Inc., cleared under FDA 510(k) K141246 on 22 Feb 2015 and listed in FDA GUDID since 7 Nov 2019 (UDI-DI 00190837062712), 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 | Number00190837062712 | Date7 Nov 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK141246 | Date22 Feb 2015 | StatusActive |
Official records
- AccessGUDID record 00190837062712
- FDA 510(k) database K141246
Across registries
- FDA 510(k) K141246 decided 22 Feb 2015 Active
- FDA GUDID UDI-DI 00190837062712 listed 7 Nov 2019 Listed
Timeline
- Cleared FDA 510(k) K141246
- Listed FDA GUDID 00190837062712
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Simpact Tri-Fin
- Generic name
- Endoscopic-access dilator, reusable
- Model / Ref / Catalog
- 152-112
- Primary DI / UDI-DI
- 00190837062712
- 510(k) Number
- FDA product code
- OUR
- GMDN term
- Endoscopic-access dilator, reusable
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Endoscopic-access dilator, reusable.