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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 K960692
Device Name SUBTALAR MBA SYSTEM
Applicant
Kinetikos Medical, Inc.
3950 Sorrento Valley Blvd.,
San Diego,  CA  92121
Applicant Contact MARK G URBANSKI
Correspondent
Kinetikos Medical, Inc.
3950 Sorrento Valley Blvd.,
San Diego,  CA  92121
Correspondent Contact MARK G URBANSKI
Regulation Number888.3040
Classification Product Code
HWC  
Date Received02/20/1996
Decision Date 07/23/1996
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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