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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Bone, Vertebroplasty
510(k) Number K132620
Device Name INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL
Applicant
Pan Medical , Ltd.
Barnett Way
Gloucester, Gloucestershire,  GB GL4 3RT
Applicant Contact JENNIE BUDDING
Correspondent
Pan Medical , Ltd.
Barnett Way
Gloucester, Gloucestershire,  GB GL4 3RT
Correspondent Contact JENNIE BUDDING
Regulation Number888.3027
Classification Product Code
NDN  
Subsequent Product Code
HRX  
Date Received08/21/2013
Decision Date 04/16/2014
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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