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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 K051611
Device Name MBARESORB IMPLANT
Applicant
KINETIKOS MEDICAL, INC.
6005 HIDDEN VALLEY RD, STE 180
CARLSBAD,  CA  92011
Applicant Contact JOHN G SPAMPINATO
Correspondent
KINETIKOS MEDICAL, INC.
6005 HIDDEN VALLEY RD, STE 180
CARLSBAD,  CA  92011
Correspondent Contact JOHN G SPAMPINATO
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Codes
MBJ   MJW  
Date Received06/17/2005
Decision Date 09/06/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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