510(k) K870417— RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY

Substantially Equivalent

North Coast Medi-Tek

Clearance details

Applicant: North Coast Medi-Tek
Product code: Code FSM
Advisory panel: General, Plastic Surgery
Date received: 1987-02-03
Decision date: 1987-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, US

Adverse events under product code FSM

product code FSM

Malfunction: 1,289
Total: 1,289

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.