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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Posterior Cervical Screw System
510(k) Number K150650
Device Name neon3
Applicant
ULRICH GMBH & CO. KG
BUCHBRUNNENWEG 12
ULM,  DE 89081
Applicant Contact Christoph Ulrich
Correspondent
ulrich medical USA
18221 Edison Avenue
Chesterfield,  MO  63005
Correspondent Contact Hans Stover
Regulation Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
KWP  
Date Received03/12/2015
Decision Date 09/24/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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