ALIGN RADIAL HEAD SYSTEM— 510(k) K092721

Substantially Equivalent

Skeletal Dynamics, LLC

FDA 510(k) clearance K092721 for ALIGN RADIAL HEAD SYSTEM, Substantially Equivalent on 2010-08-03. Applicant: Skeletal Dynamics, LLC.

Clearance details

Applicant: Skeletal Dynamics, LLC
Product code: Code KWI
Advisory panel: Orthopedic
Date received: 2009-09-04
Decision date: 2010-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shelton, CT, 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.