MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System— 510(k) K162194

Substantially Equivalent

Medicrea International SA

FDA 510(k) clearance K162194 for MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System, Substantially Equivalent on 2016-12-08. Applicant: Medicrea International SA.

Clearance details

Applicant: Medicrea International SA
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2016-08-05
Decision date: 2016-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neyron, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.