ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056— 510(k) K053094

Name: FDA 510(k) clearance K053094
Creator: U.S. Food and Drug Administration
Published: 2006-02-06

Substantially Equivalent

Advanced Bio-Surfaces, Inc.

FDA 510(k) clearance K053094 for ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056, Substantially Equivalent on 2006-02-06. Applicant: Advanced Bio-Surfaces, Inc.. Device class: 2.

Clearance details

Applicant: Advanced Bio-Surfaces, Inc.
Product code: Code HSH
Device class: Class 2
Regulation: 21 CFR 888.3590
Advisory panel: Orthopedic
Date received: 2005-11-03
Decision date: 2006-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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