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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cerclage, Fixation
510(k) Number K993286
Device Name PIONEER SILICOAT STERNAL CABLE
Applicant
Pioneer Surgical Technology
375 River Park Cir.
Marquette,  MI  49855
Applicant Contact AMY H MIMMAERTS
Correspondent
Pioneer Surgical Technology
375 River Park Cir.
Marquette,  MI  49855
Correspondent Contact AMY H MIMMAERTS
Regulation Number888.3010
Classification Product Code
JDQ  
Date Received10/01/1999
Decision Date 11/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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