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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 K181262
Device Name SpineJack Expansion Kit
Applicant
Vexim SA
8 Rue Vidailhan
Balma,  FR 31130
Applicant Contact Vincent Gardes
Correspondent
Hogan Lovells US LLP
1735 Market St.
23rd Floor
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number888.3027
Classification Product Code
NDN  
Date Received05/11/2018
Decision Date 08/30/2018
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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