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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, cervical
510(k) Number K190618
Device Name RIGEL PEEK Anterior Cervical Interbody Fusion System
MiRus, LLC
2150 Newmarket Parkway
marietta,  GA  30067
Applicant Contact jordan bauman
MiRus, LLC
2150 Newmarket Parkway
marietta,  GA  30067
Correspondent Contact jordan bauman
Regulation Number888.3080
Classification Product Code
Date Received03/11/2019
Decision Date 06/06/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No