SYNTHES RADIAL HEAD PROSTHESIS SYSTEM— 510(k) K112030

Substantially Equivalent

Synthes USA, LLC

FDA 510(k) clearance K112030 for SYNTHES RADIAL HEAD PROSTHESIS SYSTEM, Substantially Equivalent on 2012-06-19. Applicant: Synthes USA, LLC.

Clearance details

Applicant: Synthes USA, LLC
Product code: Code KWI
Advisory panel: Orthopedic
Date received: 2011-07-15
Decision date: 2012-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

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.