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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, shoulder, hemi-, humeral, metallic uncemented
510(k) Number K112983
Model SPS0021, SPS0121
Device Name SPACER-S
Original Applicant
7 trail house court
rockville,  MD  20850
Original Contact christine brauer
Regulation Number888.3690
Classification Product Code
Subsequent Product Code
Date Received10/06/2011
Decision Date 12/12/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product Yes