FDA.reportPublic FDA data

Omnia Medical TiBrid™-TS

Primary DI
00843511102791
Brand
Omnia Medical TiBrid™-TS
Company
OMNIA MEDICAL, LLC
Model
09-0P-102611-10
Device description
TiBrid™ TS Interbody, 26x11x10mm, 10°
Published
2026-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190363000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190363000Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF CageOmnia Medical, LLC2020-02-21MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843511102791PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843511102791008435111027918435111027910843511102791

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Contacts#

Phone, Email table
PhoneEmail
304-413-4851customerservice@omniamedical.com

Regulatory Flags#

DUNS number
079467378
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843511102586Omnia Medical TiBrid™-TS09-0P-102208-102026-08-03
00843511102593Omnia Medical TiBrid™-TS09-0P-102209-102026-08-03
00843511102609Omnia Medical TiBrid™-TS09-0P-102210-102026-08-03
00843511102616Omnia Medical TiBrid™-TS09-0P-102211-102026-08-03
00843511102623Omnia Medical TiBrid™-TS09-0P-102212-102026-08-03
00843511102630Omnia Medical TiBrid™-TS09-0P-102213-102026-08-03
00843511102647Omnia Medical TiBrid™-TS09-0P-102214-102026-08-03
00843511102654Omnia Medical TiBrid™-TS09-0P-102215-102026-08-03
00843511102661Omnia Medical TiBrid™-TS09-0P-102216-102026-08-03
00843511102678Omnia Medical TiBrid™-TS09-0P-102209-152026-08-03
00843511102685Omnia Medical TiBrid™-TS09-0P-102210-152026-08-03
00843511102692Omnia Medical TiBrid™-TS09-0P-102211-152026-08-03
00843511102708Omnia Medical TiBrid™-TS09-0P-102212-152026-08-03
00843511102715Omnia Medical TiBrid™-TS09-0P-102213-152026-08-03
00843511102722Omnia Medical TiBrid™-TS09-0P-102214-152026-08-03
00843511102739Omnia Medical TiBrid™-TS09-0P-102215-152026-08-03
00843511102746Omnia Medical TiBrid™-TS09-0P-102216-152026-08-03
00843511102753Omnia Medical TiBrid™-TS09-0P-102607-102026-08-03
00843511102760Omnia Medical TiBrid™-TS09-0P-102608-102026-08-03
00843511102777Omnia Medical TiBrid™-TS09-0P-102609-102026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843511102586Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102586Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102593Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102593Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102609Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102609Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102616Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102616Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102623Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102623Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102630Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102630Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102647Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102647Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102654Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102654Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102661Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102661Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102678Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102678Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102685Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102685Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102692Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102692Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102708Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102708Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102715Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102715Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102722Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102722Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03