APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM— 510(k) K083612

Substantially Equivalent

Cayenne Medical, Inc.

FDA 510(k) clearance K083612 for APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM, Substantially Equivalent on 2009-03-04. Applicant: Cayenne Medical, Inc..

Clearance details

Applicant: Cayenne Medical, Inc.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2008-12-05
Decision date: 2009-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scottsdale, AZ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.