Align Radial Head System— 510(k) K172688

Substantially Equivalent

Skeletal Dynamics, LLC

FDA 510(k) clearance K172688 for Align Radial Head System, Substantially Equivalent on 2017-12-22. Applicant: Skeletal Dynamics, LLC.

Clearance details

Applicant: Skeletal Dynamics, LLC
Product code: Code KWI
Advisory panel: Orthopedic
Date received: 2017-09-06
Decision date: 2017-12-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Miami, FL, 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.