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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name screw, fixation, bone
510(K) Number K121277
Device Name Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE
Applicant
Z-MEDICAL GMBH & CO. KG
gansacker 38
tuttlingen, baden-wuerttemberg, 
Contact alexander henninger
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Codes
HTY   JDR  
Date Received04/27/2012
Decision Date 11/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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