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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name appliance, fixation, spinal intervertebral body
510(k) Number K190565
Device Name Cervical Plate
Applicant
EiserTech, LLC
9988 Hibert Street Suite 302
San Diego,  CA  92131
Applicant Contact Lukas Eisermann
Correspondent
MRC-X, LLC
6075 Poplar Ave
Memphis,  TN  38119
Correspondent Contact Dawn Norman
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received03/05/2019
Decision Date 05/31/2019
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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