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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name External Mandibular Fixator And/Or Distractor
510(k) Number K162594
Device Name Craniomaxillofacial Distraction System (CMFD)
Applicant
SYNTHES USA PRODUCTS, LLC
1301 GOSHEN PARKWAY
WEST CHESTER,  PA  19380
Applicant Contact NICHOLAS FOUNTOULAKIS
Correspondent
SYNTHES USA PRODUCTS, LLC
1301 GOSHEN PARKWAY
WEST CHESTER,  PA  19380
Correspondent Contact NICHOLAS FOUNTOULAKIS
Regulation Number872.4760
Classification Product Code
MQN  
Date Received09/16/2016
Decision Date 05/08/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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