Omnia Medical Rotary PLIF System

Intervertebral Fusion Device With Bone Graft, Lumbar

Omnia Medical, LLC

The following data is part of a premarket notification filed by Omnia Medical, Llc with the FDA for Omnia Medical Rotary Plif System.

Pre-market Notification Details

Device IDK183659
510k NumberK183659
Device Name:Omnia Medical Rotary PLIF System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Omnia Medical, LLC 6 Canyon Rd Suite 300 Morgantown,  WV  26508
ContactTroy Schifano
CorrespondentDaniel Johnson
JALEX Medical 30311 Clemens Road Suite 5D Westlake,  OH  44145
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-27
Decision Date2019-02-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00843511100612 K183659 000
00843511100537 K183659 000
00843511100544 K183659 000
00843511100551 K183659 000
00843511100568 K183659 000
00843511100575 K183659 000
00843511100582 K183659 000
00843511100599 K183659 000
00843511100605 K183659 000
00843511100520 K183659 000

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