INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM— 510(k) K132250

Name: FDA 510(k) clearance K132250
Creator: U.S. Food and Drug Administration
Published: 2014-03-24

Substantially Equivalent

Integra LifeSciences Corporation

FDA 510(k) clearance K132250 for INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM, Substantially Equivalent on 2014-03-24. Applicant: Integra LifeSciences Corporation. Device class: 2.

Clearance details

Applicant: Integra LifeSciences Corporation
Product code: Code JWJ
Device class: Class 2
Regulation: 21 CFR 888.3800
Advisory panel: Orthopedic
Date received: 2013-07-19
Decision date: 2014-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Planisboro, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JWJ

product code JWJ

Injury: 181
Total: 181

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.