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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Interlaminal
510(k) Number K112757
Device Name PIONEER POSTERIOR CERVICO THORACIC SYSTEM
Applicant
PIONEER SURGICAL TECHNOLOGY, INC.
375 RIVER PARK CIRCLE
MARQUETTE,  MI  49855
Applicant Contact EMILY M DOWNS
Correspondent
PIONEER SURGICAL TECHNOLOGY, INC.
375 RIVER PARK CIRCLE
MARQUETTE,  MI  49855
Correspondent Contact EMILY M DOWNS
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI  
Date Received09/22/2011
Decision Date 03/12/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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