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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 K150582
Device Name Vertaplex® High Viscosity (HV) Radiopaque Bone Cement
Applicant
STRYKER CORPORATION
4100 E. MILHAM AVENUE
KALAMAZOO,  MI  49001
Applicant Contact KRISTI ASHTON
Correspondent
STRYKER CORPORATION
4100 E. MILHAM AVENUE
KALAMAZOO,  MI  49001
Correspondent Contact KRISTI ASHTON
Regulation Number888.3027
Classification Product Code
NDN  
Subsequent Product Code
LOD  
Date Received03/09/2015
Decision Date 06/12/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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