SEARCH EVOLUTION TOTAL KNEE SYSTEM— 510(k) K021313

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K021313 for SEARCH EVOLUTION TOTAL KNEE SYSTEM, Substantially Equivalent on 2002-07-22. Applicant: Aesculap, Inc..

Clearance details

Applicant
Aesculap, Inc.
Product code
Code JWH
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Center Valley, PA, US
Download summary PDFView on FDA.gov ↗

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, through . 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.