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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Toe, Hemi-, Phalangeal
510(k) Number K023770
Device Name K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM)
Applicant
Kinetikos Medical, Inc.
4115 Sorrento Valley Blvd.
San Diego,  CA  92121
Applicant Contact JOHN SPAMPINATO
Correspondent
Kinetikos Medical, Inc.
4115 Sorrento Valley Blvd.
San Diego,  CA  92121
Correspondent Contact JOHN SPAMPINATO
Regulation Number888.3730
Classification Product Code
KWD  
Date Received11/12/2002
Decision Date 12/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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