Solanas® Posterior OCT Fixation System— 510(k) K191185

Clearance details

Applicant

Alphatec Spine

Product code

Code NKG

Device class

Class 2

Regulation

21 CFR 888.3075

Advisory panel

Orthopedic

Date received

2019-05-03

Decision date

2019-06-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Carlsnad, CA, US

• K253195 — TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems2026-06-02
• K254045 — CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System2026-03-16
• K254165 — Infinity OCT System2026-01-21
• K252327 — CMORE® CT System; CMORE® CT System Navigated Instruments2025-11-12
• K253129 — Infinity OCT System2025-10-24

• 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
• K222028 — 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 System2022-10-07
• K160958 — Battalion Universal Spacer System2016-09-08

Death

15

Injury

1,090

Malfunction

529

Total

1,634

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 →