TORNIER BIPOLAR RADIAL HEAD PROSTHESIS— 510(k) K994041

Substantially Equivalent

Tornier, Inc.

FDA 510(k) clearance K994041 for TORNIER BIPOLAR RADIAL HEAD PROSTHESIS, Substantially Equivalent on 2000-08-31. Applicant: Tornier, Inc..

Clearance details

Applicant: Tornier, Inc.
Product code: Code KWI
Advisory panel: Orthopedic
Date received: 1999-11-29
Decision date: 2000-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasant Hill, CA, US

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Adverse events under product code KWI

product code KWI

Injury: 490
Total: 490

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.