PASS OCT SPINAL SYSTEM— 510(k) K121979

Substantially Equivalent

Medicrea International

FDA 510(k) clearance K121979 for PASS OCT SPINAL SYSTEM, Substantially Equivalent on 2013-03-21. Applicant: Medicrea International.

Clearance details

Applicant: Medicrea International
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 2012-07-06
Decision date: 2013-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neyron, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.