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

Substantially Equivalent

Medicrea International

FDA 510(k) clearance K220810 for Infinity OCT System and PASS OCT Spinal System, Substantially Equivalent on 2022-04-19. Applicant: Medicrea International.

Clearance details

Applicant: Medicrea International
Product code: Code NKG
Advisory panel: Orthopedic
Date received: 2022-03-21
Decision date: 2022-04-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Rillieux-La-Pape, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKG

product code NKG

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.