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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with integrated fixation, lumbar
510(k) Number K093629
Device Name SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM
Applicant
BIOMET SPINE
100 INTERPACE PARKWAY
PARSIPPANY,  NJ  07054
Applicant Contact VIVIAN KELLY
Correspondent
BIOMET SPINE
100 INTERPACE PARKWAY
PARSIPPANY,  NJ  07054
Correspondent Contact VIVIAN KELLY
Regulation Number888.3080
Classification Product Code
OVD  
Subsequent Product Code
MQP  
Date Received11/23/2009
Decision Date 03/09/2010
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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