Infinity OCT System and PASS OCT Spinal System— 510(k) K220810

Clearance details

Applicant

Medicrea International

Product code

Code NKG

Device class

Class 2

Regulation

21 CFR 888.3075

Advisory panel

Orthopedic

Date received

2022-03-21

Decision date

2022-04-19

Decision

Substantially Equivalent

Clearance type

Special

Location

Rillieux-La-Pape, FR

• 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

• K220724 — CD Horizon Spinal System and PASS LP Spinal System2022-04-08
• K180091 — UNiD Spine Analyzer2018-02-08
• K170172 — UNiD Spine Analyzer2017-05-24
• K153169 — PASS OCT Patient Specific Rods2016-01-29
• K150049 — PASS LP Spinal System2015-02-10

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 →