FDA.reportPublic FDA data

Omnia Medical TiBrid™-TS

Primary DI
00843511102821
Brand
Omnia Medical TiBrid™-TS
Company
OMNIA MEDICAL, LLC
Model
09-0P-102614-10
Device description
TiBrid™ TS Interbody, 26x14x10mm, 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
00843511102821PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843511102821008435111028218435111028210843511102821

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
00843511102852Omnia Medical TiBrid™-TS09-0P-102609-152026-08-18
00843511102869Omnia Medical TiBrid™-TS09-0P-102610-152026-08-18
00843511102876Omnia Medical TiBrid™-TS09-0P-102611-152026-08-18
00843511102883Omnia Medical TiBrid™-TS09-0P-102612-152026-08-18
00843511102890Omnia Medical TiBrid™-TS09-0P-102613-152026-08-18
00843511102906Omnia Medical TiBrid™-TS09-0P-102614-152026-08-18
00843511102913Omnia Medical TiBrid™-TS09-0P-102615-152026-08-18
00843511102920Omnia Medical TiBrid™-TS09-0P-102616-152026-08-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017916139SABER-XA, Anterior Plate, 34Wx11HELEVATION SPINE, INC.MAX2026-10-23
00810017916146SABER-XA, Anterior Plate, 34Wx13HELEVATION SPINE, INC.MAX2026-10-23
00810017916153SABER-XA, Anterior Plate, 34Wx16HELEVATION SPINE, INC.MAX2026-10-23
00810017916207SABER-XA, Anterior Plate, 37Wx11HELEVATION SPINE, INC.MAX2026-10-23
00810017916221SABER-XA, Anterior Plate, 37Wx16HELEVATION SPINE, INC.MAX2026-10-23
00810017916276SABER-XA, Anterior Plate, 40Wx11HELEVATION SPINE, INC.MAX2026-10-23
00810017916283SABER-XA, Anterior Plate, 40Wx13HELEVATION SPINE, INC.MAX2026-10-23
00810017916290SABER-XA, Anterior Plate, 40Wx16HELEVATION SPINE, INC.MAX2026-10-23
00840606176347LucentSPINAL ELEMENTS, INC.MAX2026-10-22
00840606184847LucentSPINAL ELEMENTS, INC.MAX2026-10-22
00840606197106LucentSPINAL ELEMENTS, INC.MAX2026-10-22
B648C29510000Savant Lumbar Interbody Fusion SystemCURITEVA, INC.MAX2026-10-19
M719GLL11403DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
M719GLL11503DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
M719GLL11603DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
00810161900381EARP, 14X25X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900398EARP, 14X25X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900404EARP, 14X25X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900411EARP, 14X25X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900428EARP, 14X30X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900435EARP, 14X30X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900442EARP, 14X30X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900459EARP, 14X30X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900466EARP, 14X35X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
B6785221380Tranquil-L™NEXUS SPINE, L.L.C.MAX2021-12-17
B6785221390Tranquil-L™NEXUS SPINE, L.L.C.MAX2021-12-17
B6785221400Tranquil-L™NEXUS SPINE, L.L.C.MAX2021-12-17
B6785221410Tranquil-L™NEXUS SPINE, L.L.C.MAX2021-12-17
B6785221420Tranquil-L™NEXUS SPINE, L.L.C.MAX2021-12-17
B6785221430Tranquil-L™NEXUS SPINE, L.L.C.MAX2021-12-17