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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,  DE 78532
Applicant Contact ALEXANDER HENNINGER
Correspondent
Z-Medical GmbH & Co. KG
Gansacker 38
Tuttlingen, Baden-Wuerttemberg,  DE 78532
Correspondent 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 (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
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