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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Wrist, Hemi-, Ulnar
510(k) Number K061146
Device Name SBI ULNAR HEAD 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 Number888.3810
Classification Product Code
KXE  
Date Received04/25/2006
Decision Date 07/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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