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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 K062898
Device Name SBI LATERAL RHEAD IMPLANT
Applicant
SMALL BONE INNOVATIONS INC.
505 PARK AVE., 14TH FLOOR
NEW YORK,  NY  10022
Applicant Contact ROBERT HOEHN
Correspondent
SMALL BONE INNOVATIONS INC.
505 PARK AVE., 14TH FLOOR
NEW YORK,  NY  10022
Correspondent Contact ROBERT HOEHN
Regulation Number888.3170
Classification Product Code
KWI  
Date Received09/27/2006
Decision Date 11/13/2006
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
Recalls CDRH Recalls
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