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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name appliance, fixation, nail/blade/plate combination, multiple component
510(k) Number K152755
Device Name FastFrame External Fixation System-Ankle Spanning
Zimmer, Inc.
345 East Main Street
Warsaw,  IN  46580
Applicant Contact Dorothy Snyder
Zimmer, Inc.
P.O. Box 708
Warsaw,  IN  46851 -0708
Correspondent Contact Sujith M. Kallur
Regulation Number888.3030
Classification Product Code
Subsequent Product Code
Date Received09/24/2015
Decision Date 12/21/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No