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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 K121725
Device Name PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM
Applicant
PIONEER SURGICAL TECHNOLOGY, INC
375 RIVER PARK CIRCLE
MARQUETTE,  MI  49855
Applicant Contact SARAH MCINTYRE
Correspondent
PIONEER SURGICAL TECHNOLOGY, INC
375 RIVER PARK CIRCLE
MARQUETTE,  MI  49855
Correspondent Contact SARAH MCINTYRE
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI  
Date Received06/12/2012
Decision Date 11/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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