MARTIN-CHAMPY TITAN SET— 510(k) K884523

Substantially Equivalent

Buschmann Surgical Products

FDA 510(k) clearance K884523 for MARTIN-CHAMPY TITAN SET, Substantially Equivalent on 1988-12-08. Applicant: Buschmann Surgical Products.

Clearance details

Applicant: Buschmann Surgical Products
Product code: Code JEY
Advisory panel: Dental
Date received: 1988-10-27
Decision date: 1988-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reno, NV, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JEY

product code JEY

Injury: 1,542
Malfunction: 2,292
Total: 3,834

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.