CONSERVE PRESSFIT FEMORAL COMPONENT— 510(k) K082673

Name: FDA 510(k) clearance K082673
Creator: U.S. Food and Drug Administration
Published: 2008-12-12

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K082673 for CONSERVE PRESSFIT FEMORAL COMPONENT, Substantially Equivalent on 2008-12-12. Applicant: Wrightmedicaltechnologyinc. Device class: 2.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code KXA
Device class: Class 2
Regulation: 21 CFR 888.3400
Advisory panel: Orthopedic
Date received: 2008-09-15
Decision date: 2008-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KXA

product code KXA

Injury: 324
Total: 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.