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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 K162453
Device Name 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)
Applicant
Pan Medical , Ltd.
Barnett Way, Barnwood
Gloucester,  GB GL4 3RT
Applicant Contact Jennie Budding
Correspondent
Pan Medical , Ltd.
Barnett Way, Barnwood
Gloucester,  GB GL4 3RT
Correspondent Contact Jennie Budding
Regulation Number888.3027
Classification Product Code
NDN  
Subsequent Product Code
HRX  
Date Received09/01/2016
Decision Date 11/01/2016
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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