Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage

Intervertebral Fusion Device With Bone Graft, Cervical

Medynus Inc.

The following data is part of a premarket notification filed by Medynus Inc. with the FDA for Medynus Iva (acif, Dlif, Plif, Tlif, Alif) Peek Cage.

Pre-market Notification Details

Device IDK212792
510k NumberK212792
Device Name:Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant Medynus Inc. 18 Technology Dr. Ste 109 Irvine,  CA  92618
ContactDavid Shin
CorrespondentJeena Mathai
Eerkie Corporation 4027 Runnymeade Dr Collegeville,  PA  19426
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-01
Decision Date2021-09-23

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