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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 K950704
Device Name K4 BONE SCREW 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 Received02/15/1995
Decision Date 06/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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