Omnia Medical Rotary PLIF STF-017-014

GUDID 00843511100612

Omnia Medical Rotary PLIF 17mm Parallel

OMNIA MEDICAL, LLC

Polymeric spinal interbody fusion cage
Primary Device ID00843511100612
NIH Device Record Key3e3a9ff6-1853-4f13-aa45-8e37cf51a9f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmnia Medical Rotary PLIF
Version Model NumberSTF-017-014
Catalog NumberSTF-017-014
Company DUNS079467378
Company NameOMNIA MEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone3044134851
Emailcustomerservice@omniamedical.com

Device Dimensions

Height17 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100843511100612 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00843511100612]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-02-24
Device Publish Date2019-07-08

On-Brand Devices [Omnia Medical Rotary PLIF]

00843511100612Omnia Medical Rotary PLIF 17mm Parallel
00843511100605Omnia Medical Rotary PLIF 15mm Parallel
00843511100599Omnia Medical Rotary PLIF 13mm Parallel
00843511100582Omnia Medical Rotary PLIF 11mm Parallel
00843511100575Omnia Medical Rotary PLIF 9mm Parallel
00843511100568Omnia Medical Rotary PLIF 17mm Lordotic
00843511100551Omnia Medical Rotary PLIF 15mm Lordotic
00843511100544Omnia Medical Rotary PLIF 13mm Lordotic
00843511100537Omnia Medical Rotary PLIF 11mm Lordotic
00843511100520Omnia Medical Rotary PLIF 9mm Lordotic

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