EXPRT Revision Hip System— 510(k) K161610

Substantially Equivalent

Encore Medical L.P.

FDA 510(k) clearance K161610 for EXPRT Revision Hip System, Substantially Equivalent on 2016-11-09. Applicant: Encore Medical L.P..

Clearance details

Applicant: Encore Medical L.P.
Product code: Code KWZ
Advisory panel: Orthopedic
Date received: 2016-06-10
Decision date: 2016-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWZ

product code KWZ

Injury: 993
Total: 993

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.