APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W— 510(k) K122463

Substantially Equivalent

Cayenne Medical, Inc.

FDA 510(k) clearance K122463 for APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W, Substantially Equivalent on 2012-10-11. Applicant: Cayenne Medical, Inc..

Clearance details

Applicant: Cayenne Medical, Inc.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2012-08-13
Decision date: 2012-10-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Scottsdale, AZ, US

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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.