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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Cement, Posterior Screw Augmentation
510(k) Number K192818
Device Name Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System
Applicant
Stryker Corporation
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Applicant Contact Kristi Ashton
Correspondent
Stryker Corporation
4100 E. Milham Ave.
Kalamazoo,  MI  49001
Correspondent Contact Kristi Ashton
Regulation Number888.3027
Classification Product Code
PML  
Subsequent Product Codes
MNI   NDN   NKB  
Date Received10/01/2019
Decision Date 03/31/2020
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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