IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend PEEK Interbody System, Transcend NanoTec Interbody System, IdentiTi ALIF Standalone Interbody System, IdentiTi NanoTec ALIF Standalone Interbody System— 510(k) K222028

Clearance details

Applicant

Alphatec Spine

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2022-07-11

Decision date

2022-10-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Carlsbad, CA, US

• K261049 — SCALA® TL2026-08-20
• K261430 — TruLift Expandable System2026-07-28
• K253011 — Catalyft PL Expandable Interbody System2026-07-17
• K261020 — Symmetrix L Spinal System2026-07-14
• K253420 — Admiral ACP System +18 more2026-07-01

• K251575 — IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System2025-09-03
• K241375 — IdentiTi Porous Ti Interbody System +11 more2025-02-03
• K240951 — Invictus Robotic Navigation Instruments2024-06-06
• K191185 — Solanas® Posterior OCT Fixation System2019-06-03
• K160958 — Battalion Universal Spacer System2016-09-08

Death

13

Injury

1,305

Malfunction

2,885

Total

4,203

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →