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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, Semi-Constrained, Cemented
510(k) Number K070236
Device Name SBI LATERAL RADIO CAPITELLUM
Applicant
Small Bone Innovations, Inc.
505 Park Ave., 14th Floor
Newyork,  NY 
Applicant Contact ROBERT HOEHN
Correspondent
Small Bone Innovations, Inc.
505 Park Ave., 14th Floor
Newyork,  NY 
Correspondent Contact ROBERT HOEHN
Regulation Number888.3160
Classification Product Code
JDB  
Date Received01/25/2007
Decision Date 02/21/2007
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
Recalls CDRH Recalls
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