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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Elbow, Hemi-, Radial, Polymer
510(k) Number K032806
Device Name KATALYST RADIAL HEAD IMPLANT
Applicant
Kinetikos Medical, Inc.
6005 Hidden Valley Rd., Suite 180
Carlsbad,  CA  92011
Applicant Contact JOHN G SPAMPINATO
Correspondent
Kinetikos Medical, Inc.
6005 Hidden Valley Rd., Suite 180
Carlsbad,  CA  92011
Correspondent Contact JOHN G SPAMPINATO
Regulation Number888.3170
Classification Product Code
KWI  
Date Received09/09/2003
Decision Date 04/16/2004
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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