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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 K024233
Device Name KOMPRESSOR SCREW SYSTEM
Applicant
Kinetikos Medical, Inc.
6005 Hidden Valley Rd.
Carlsbad,  CA  92009
Applicant Contact JOHN G SPAMPINATO
Correspondent
Kinetikos Medical, Inc.
6005 Hidden Valley Rd.
Carlsbad,  CA  92009
Correspondent Contact JOHN G SPAMPINATO
Regulation Number888.3040
Classification Product Code
HWC  
Date Received12/23/2002
Decision Date 02/06/2003
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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