STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5— 510(k) K111068

Name: FDA 510(k) clearance K111068
Creator: U.S. Food and Drug Administration
Published: 2011-12-30

Substantially Equivalent

Skeletal Dynamics, LLC

FDA 510(k) clearance K111068 for STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5, Substantially Equivalent on 2011-12-30. Applicant: Skeletal Dynamics, LLC. Device class: 2.

Clearance details

Applicant: Skeletal Dynamics, LLC
Product code: Code KYI
Device class: Class 2
Regulation: 21 CFR 888.3770
Advisory panel: Orthopedic
Date received: 2011-04-18
Decision date: 2011-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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