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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K021335
Device Name MONARCH SPINE SYSTEM
Applicant
Depuyacromed
325 Paramount Dr.
Raynham,  MA  02767 -0350
Applicant Contact LISA GILMAN
Correspondent
Depuyacromed
325 Paramount Dr.
Raynham,  MA  02767 -0350
Correspondent Contact LISA GILMAN
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   MNI  
Date Received04/26/2002
Decision Date 07/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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