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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 K211238
Device Name SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement
Applicant
Stryker Instruments
1941 Stryker Way
Kalamazoo,  MI  49002
Applicant Contact Susanne Galin
Correspondent
Stryker Instruments
1941 Stryker Way
Kalamazoo,  MI  49002
Correspondent Contact Susanne Galin
Regulation Number888.3027
Classification Product Code
NDN  
Subsequent Product Codes
LOD   PML  
Date Received04/26/2021
Decision Date 06/25/2021
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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