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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 K011182
Device Name MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS
Applicant
Depuyacromed
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact LISA GILMAN
Correspondent
Depuyacromed
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact LISA GILMAN
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   MNI  
Date Received04/18/2001
Decision Date 05/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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