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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 K061454
Device Name EXACTECH EQUINOXE SHOULDER STEMS
Applicant
EXACTECH, INC.
2320 N.W. 66TH CT.
GAINESVILLE,  FL  32653
Applicant Contact MARITZA ELIAS
Correspondent
EXACTECH, INC.
2320 N.W. 66TH CT.
GAINESVILLE,  FL  32653
Correspondent Contact MARITZA ELIAS
Regulation Number888.3690
Classification Product Code
HSD  
Subsequent Product Code
KWS  
Date Received05/25/2006
Decision Date 06/12/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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