INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM— 510(k) K132250
Substantially EquivalentIntegra LifeSciences Corporation
FDA 510(k) clearance K132250 for INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM, Substantially Equivalent on 2014-03-24. Applicant: Integra LifeSciences Corporation.
Clearance details
- Applicant
- Integra LifeSciences Corporation
- Product code
- Code JWJ
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Planisboro, NJ, US
Adverse events under product code JWJ
product code JWJ- Injury
- 181
- Total
- 181
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.