FEMORAL HOOK— 510(k) K041261

Substantially Equivalent

Arthrotek, Inc.

FDA 510(k) clearance K041261 for FEMORAL HOOK, Substantially Equivalent on 2004-06-07. Applicant: Arthrotek, Inc..

Clearance details

Applicant: Arthrotek, Inc.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2004-05-11
Decision date: 2004-06-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.