FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT— 510(k) K091280

Substantially Equivalent

Maxx Orthopedics, Inc.

FDA 510(k) clearance K091280 for FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT, Substantially Equivalent on 2009-09-25. Applicant: Maxx Orthopedics, Inc..

Clearance details

Applicant: Maxx Orthopedics, Inc.
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 2009-05-01
Decision date: 2009-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

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Adverse events under product code JWH

product code JWH

Death: 26
Injury: 51,564
Malfunction: 9,725
Other: 9
Total: 61,324

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.