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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 K923032
Device Name FIXEL EXTERNAL FIXATION DEVICE
Applicant
Amp, Inc.
1054 31st St. NW
Washington,  DC  20007
Applicant Contact ISABELLE FLOCCOIA
Correspondent
Amp, Inc.
1054 31st St. NW
Washington,  DC  20007
Correspondent Contact ISABELLE FLOCCOIA
Regulation Number888.3030
Classification Product Code
KTT  
Date Received06/23/1992
Decision Date 10/04/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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