IdentiTi 123-09093500
IdentiTi 123-09093500 is a Class II device made by Alphatec Spine, Inc., cleared under FDA 510(k) K183705 on 1 Mar 2019 and listed in FDA GUDID since 20 Oct 2020 (UDI-DI 00190376246123), 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 | Number00190376246123 | Date20 Oct 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK183705 | Date1 Mar 2019 | StatusActive |
Official records
- AccessGUDID record 00190376246123
- FDA 510(k) database K183705
Across registries
- FDA 510(k) K183705 decided 1 Mar 2019 Active
- FDA GUDID UDI-DI 00190376246123 listed 20 Oct 2020 Listed
Timeline
- Cleared FDA 510(k) K183705
- Listed FDA GUDID 00190376246123
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- IdentiTi
- Generic name
- Spinal implant trial
- Model / reference
- 123-09093500
- Primary DI / UDI-DI
- 00190376246123
- 510(k) Number
- FDA product code
- MAX, PHM
- GMDN term
- Spinal implant trial
- Device class
- Class II
- Regulation number
- 888.3080
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- Size
- Width — 9 MillimeterHeight — 9 MillimeterLength — 35 Millimeter