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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, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K000734
Device Name PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601
Applicant
Pioneer Surgical Technology
375 River Park Cir.
Marquette,  MI  49855
Applicant Contact AMY MOMMAERTS
Correspondent
Pioneer Surgical Technology
375 River Park Cir.
Marquette,  MI  49855
Correspondent Contact AMY MOMMAERTS
Regulation Number888.3030
Classification Product Code
KTT  
Date Received03/07/2000
Decision Date 05/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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