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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 K102180
Device Name RHEAD RADIAL HEAD EXTENDED STEMS
Applicant
SMALL BONE INNOVATIONS, INC.
1380 S. PENNSYLVANIA AVE.
MORRISVILLE,  PA  19067
Applicant Contact JAMES O'CONNOR
Correspondent
SMALL BONE INNOVATIONS, INC.
1380 S. PENNSYLVANIA AVE.
MORRISVILLE,  PA  19067
Correspondent Contact JAMES O'CONNOR
Regulation Number888.3160
Classification Product Code
JDB  
Subsequent Product Code
KWI  
Date Received08/02/2010
Decision Date 12/20/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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