BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST— 510(k) K031203

Substantially Equivalent

DePuy Orthopaedics, Inc.

FDA 510(k) clearance K031203 for BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST, Substantially Equivalent on 2003-07-14. Applicant: DePuy Orthopaedics, Inc..

Clearance details

Applicant: DePuy Orthopaedics, Inc.
Product code: Code JWJ
Advisory panel: Orthopedic
Date received: 2003-04-16
Decision date: 2003-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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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.