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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K050675
Device Name EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE
Applicant
Depuy Spine, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact LISA GILMAN
Correspondent
Depuy Spine, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact LISA GILMAN
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received03/16/2005
Decision Date 04/11/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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