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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
510(k) Number K061749
Device Name ECLIPSE TOTAL ANKLE IMPLANT
Applicant
Kinetikos Medical, Inc.
6005 Hidden Valley Rd., Suite 180
Carlsbad,  CA  92011
Applicant Contact JOHN G STAMPINATO
Correspondent
Kinetikos Medical, Inc.
6005 Hidden Valley Rd., Suite 180
Carlsbad,  CA  92011
Correspondent Contact JOHN G STAMPINATO
Regulation Number888.3110
Classification Product Code
HSN  
Date Received06/21/2006
Decision Date 11/22/2006
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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