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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with bone graft, lumbar
510(k) Number K193457
Device Name AUDERE Lumbar Spacer System
Applicant
Met One Technologies
513 W. San Antonio Ave, Suite C
El Paso,  TX  79901
Applicant Contact Kyle Atwood
Correspondent
Met One Technologies
513 W. San Antonio Ave, Suite C
El Paso,  TX  79901
Correspondent Contact Evan Carbonell
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
OVD  
Date Received12/16/2019
Decision Date 05/12/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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