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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K022726
Device Name STAYFUSE GT-IP
Applicant
Pioneer Surgical Technology
375 River Park Circle
Marquette,  MI  49855 -0627
Applicant Contact KATHY MORAN
Correspondent
Pioneer Surgical Technology
375 River Park Circle
Marquette,  MI  49855 -0627
Correspondent Contact KATHY MORAN
Regulation Number888.3040
Classification Product Code
HWC  
Date Received08/16/2002
Decision Date 09/06/2002
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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