Physica PS Knee System— 510(k) K152008

Substantially Equivalent

Lima Corporate S.P.A.

FDA 510(k) clearance K152008 for Physica PS Knee System, Substantially Equivalent on 2015-10-29. Applicant: Lima Corporate S.P.A..

Clearance details

Applicant: Lima Corporate S.P.A.
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 2015-07-21
Decision date: 2015-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Villanova Di San Daniele Del Friuli, IT

Download summary PDF View 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, 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.