Omnia Medical TiBrid™-L 13-0L-225514-15

GUDID 00843511107093

LATERAL INTERBODY, 22x55x14mm, 15°

OMNIA MEDICAL, LLC

Polymeric spinal interbody fusion cage
Primary Device ID00843511107093
NIH Device Record Key2059242c-fe2b-4512-8485-61aec68431eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmnia Medical TiBrid™-L
Version Model Number13-0L-225514-15
Catalog Number13-0L-225514-15
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 Datetrue
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
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com
Phone3044134851
Emailcustomerservice@omniamedical.com

Device Dimensions

Width22 Millimeter
Length55 Millimeter
Height14 Millimeter
Angle15 degree
Width22 Millimeter
Length55 Millimeter
Height14 Millimeter
Angle15 degree
Width22 Millimeter
Length55 Millimeter
Height14 Millimeter
Angle15 degree
Width22 Millimeter
Length55 Millimeter
Height14 Millimeter
Angle15 degree
Width22 Millimeter
Length55 Millimeter
Height14 Millimeter
Angle15 degree
Width22 Millimeter
Length55 Millimeter
Height14 Millimeter
Angle15 degree
Width22 Millimeter
Length55 Millimeter
Height14 Millimeter
Angle15 degree
Width22 Millimeter
Length55 Millimeter
Height14 Millimeter
Angle15 degree
Width22 Millimeter
Length55 Millimeter
Height14 Millimeter
Angle15 degree
Width22 Millimeter
Length55 Millimeter
Height14 Millimeter
Angle15 degree
Width22 Millimeter
Length55 Millimeter
Height14 Millimeter
Angle15 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100843511107093 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-11
Device Publish Date2024-03-01

On-Brand Devices [Omnia Medical TiBrid™-L]

00843511105587LATERAL INTERBODY, 18x50x18mm, 0°
00843511105570LATERAL INTERBODY, 18x50x16mm, 0°
00843511105563LATERAL INTERBODY, 18x50x14mm, 0°
00843511105556LATERAL INTERBODY, 18x50x12mm, 0°
00843511105549LATERAL INTERBODY, 18x50x10mm, 0°
00843511105532LATERAL INTERBODY, 18x50x8mm, 0°
00843511105525LATERAL INTERBODY, 18x45x18mm, 0°
00843511105518LATERAL INTERBODY, 18x45x16mm, 0°
00843511105501LATERAL INTERBODY, 18x45x14mm, 0°
00843511105495LATERAL INTERBODY, 18x45x12mm, 0°
00843511105488LATERAL INTERBODY, 18x45x10mm, 0°
00843511105471LATERAL INTERBODY, 18x45x8mm, 0°
00843511105464LATERAL INTERBODY, 18x40x18mm, 0°
00843511105457LATERAL INTERBODY, 18x40x16mm, 0°
00843511105440LATERAL INTERBODY, 18x40x14mm, 0°
00843511105433LATERAL INTERBODY, 18x40x12mm, 0°
00843511105426LATERAL INTERBODY, 18x40x10mm, 0°
00843511105419LATERAL INTERBODY, 18x40x8mm, 0°
00843511105808LATERAL INTERBODY, 18x45x18mm, 10°
00843511105792LATERAL INTERBODY, 18x45x16mm, 10°
00843511105785LATERAL INTERBODY, 18x45x14mm, 10°
00843511105778LATERAL INTERBODY, 18x45x12mm, 10°
00843511105761LATERAL INTERBODY, 18x45x10mm, 10°
00843511105754LATERAL INTERBODY, 18x40x18mm, 10°
00843511105747LATERAL INTERBODY, 18x40x16mm, 10°
00843511105730LATERAL INTERBODY, 18x40x14mm, 10°
00843511105723LATERAL INTERBODY, 18x40x12mm, 10°
00843511105716LATERAL INTERBODY, 18x40x10mm, 10°
00843511105709LATERAL INTERBODY, 18x60x18mm, 0°
00843511105693LATERAL INTERBODY, 18x60x16mm, 0°
00843511105686LATERAL INTERBODY, 18x60x14mm, 0°
00843511105679LATERAL INTERBODY, 18x60x12mm, 0°
00843511105662LATERAL INTERBODY, 18x60x10mm, 0°
00843511105655LATERAL INTERBODY, 18x60x8mm, 0°
00843511105648LATERAL INTERBODY, 18x55x18mm, 0°
00843511105631LATERAL INTERBODY, 18x55x16mm, 0°
00843511105624LATERAL INTERBODY, 18x55x14mm, 0°
00843511105617LATERAL INTERBODY, 18x55x12mm, 0°
00843511105600LATERAL INTERBODY, 18x55x10mm, 0°
00843511105594LATERAL INTERBODY, 18x55x8mm, 0°
00843511106881LATERAL INTERBODY, 22x55x14mm, 10°
00843511106874LATERAL INTERBODY, 22x55x12mm, 10°
00843511106867LATERAL INTERBODY, 22x55x10mm, 10°
00843511106850LATERAL INTERBODY, 22x50x18mm, 10°
00843511106843LATERAL INTERBODY, 22x50x16mm, 10°
00843511106836LATERAL INTERBODY, 22x50x14mm, 10°
00843511106829LATERAL INTERBODY, 22x50x12mm, 10°
00843511106812LATERAL INTERBODY, 22x50x10mm, 10°
00843511106805LATERAL INTERBODY, 22x45x18mm, 10°
00843511106799LATERAL INTERBODY, 22x45x16mm, 10°
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.