CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING)— 510(k) K032169

Name: FDA 510(k) clearance K032169
Creator: U.S. Food and Drug Administration
Published: 2003-09-22

Substantially Equivalent

Cyberorthology, Inc.

FDA 510(k) clearance K032169 for CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING), Substantially Equivalent on 2003-09-22. Applicant: Cyberorthology, Inc.. Device class: 2.

Clearance details

Applicant: Cyberorthology, Inc.
Product code: Code LXT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2003-07-16
Decision date: 2003-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Appollo Beach, FL, US

Download summary PDF View on FDA.gov ↗

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