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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 K040432
Device Name SOLAR 2 ANATOMIC SHOULDER
Applicant
STRYKER ORTHOPAEDICS
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact GINNY STAMBERGER
Correspondent
STRYKER ORTHOPAEDICS
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact GINNY STAMBERGER
Regulation Number888.3690
Classification Product Code
HSD  
Subsequent Product Code
KWS  
Date Received02/19/2004
Decision Date 01/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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