EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS— 510(k) K092548

Name: FDA 510(k) clearance K092548
Creator: U.S. Food and Drug Administration
Published: 2009-12-15

Substantially Equivalent

Extremity Medical, LLC

FDA 510(k) clearance K092548 for EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS, Substantially Equivalent on 2009-12-15. Applicant: Extremity Medical, LLC. Device class: 2.

Clearance details

Applicant: Extremity Medical, LLC
Product code: Code KYI
Device class: Class 2
Regulation: 21 CFR 888.3770
Advisory panel: Orthopedic
Date received: 2009-08-19
Decision date: 2009-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.