RIGEL PEEK Anterior Cervical Interbody Fusion System

Intervertebral Fusion Device With Bone Graft, Cervical

MiRus, LLC

The following data is part of a premarket notification filed by Mirus, Llc with the FDA for Rigel Peek Anterior Cervical Interbody Fusion System.

Pre-market Notification Details

Device IDK190618
510k NumberK190618
Device Name:RIGEL PEEK Anterior Cervical Interbody Fusion System
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant MiRus, LLC 2150 Newmarket Parkway Marietta,  GA  30067
ContactJordan Bauman
CorrespondentJordan Bauman
MiRus, LLC 2150 Newmarket Parkway Marietta,  GA  30067
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-11
Decision Date2019-06-06

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