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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 K231809
Device Name Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement
Applicant
Ulrich Medical USA
3700 E Plano Parkway Suite 200
Plano,  TX  75074
Applicant Contact Eric Lucas
Correspondent
MCRA LLC
803 7th Street NW
Washington,  DC  20001
Correspondent Contact Michael Coladonato
Regulation Number888.3027
Classification Product Code
PML  
Subsequent Product Code
NKB  
Date Received06/20/2023
Decision Date 10/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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