Internal Joint Stabilizer - Elbow— 510(k) K153208

Name: FDA 510(k) clearance K153208
Creator: U.S. Food and Drug Administration
Published: 2015-12-31

Substantially Equivalent

Skeletal Dynamics, LLC

FDA 510(k) clearance K153208 for Internal Joint Stabilizer - Elbow, Substantially Equivalent on 2015-12-31. Applicant: Skeletal Dynamics, LLC. Device class: 2.

Clearance details

Applicant: Skeletal Dynamics, LLC
Product code: Code OZI
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2015-11-05
Decision date: 2015-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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