PASS OCT Patient Specific Rods— 510(k) K153169

Substantially Equivalent

Medicrea International

FDA 510(k) clearance K153169 for PASS OCT Patient Specific Rods, Substantially Equivalent on 2016-01-29. Applicant: Medicrea International.

Clearance details

Applicant: Medicrea International
Product code: Code NKG
Advisory panel: Orthopedic
Date received: 2015-11-02
Decision date: 2016-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neyron, 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.