FDA.reportPublic FDA data

Omnia Medical TiBrid™-A

Primary DI
00843511110109
Brand
Omnia Medical TiBrid™-A
Company
OMNIA MEDICAL, LLC
Model
14-5A-RA322512-12
Device description
TiBrid™-A RASP, 32x25x12mm, 12°
Published
2024-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00843511110109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843511110109008435111101098435111101090843511110109

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle12degree
Height12Millimeter
Length25Millimeter
Width32Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
3044134851customerservice@omniamedical.com

Regulatory Flags#

DUNS number
079467378
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843511102135Omnia Medical TiBrid™-TC08-0T-2707-72026-07-22
00843511102142Omnia Medical TiBrid™-TC08-0T-2708-708-0T-2708-72026-07-22
00843511102159Omnia Medical TiBrid™-TC08-0T-2709-708-0T-2709-72026-07-22
00843511102166Omnia Medical TiBrid™-TC08-0T-2710-708-0T-2710-72026-07-22
00843511102173Omnia Medical TiBrid™-TC08-0T-2711-708-0T-2711-72026-07-22
00843511102180Omnia Medical TiBrid™-TC08-0T-2712-708-0T-2712-72026-07-22
00843511102197Omnia Medical TiBrid™-TC08-0T-2713-708-0T-2713-72026-07-22
00843511102203Omnia Medical TiBrid™-TC08-0T-2714-708-0T-2714-72026-07-22
00843511102210Omnia Medical TiBrid™-TC08-0T-2715-708-0T-2715-72026-07-22
00843511102227Omnia Medical TiBrid™-TC08-0T-2716-708-0T-2716-72026-07-22
00843511102234Omnia Medical TiBrid™-TC08-0T-3107-708-0T-3107-72026-07-22
00843511102241Omnia Medical TiBrid™-TC08-0T-3108-708-0T-3108-72026-07-22
00843511102258Omnia Medical TiBrid™-TC08-0T-3109-708-0T-3109-72026-07-22
00843511102265Omnia Medical TiBrid™-TC08-0T-3110-708-0T-3110-72026-07-22
00843511102272Omnia Medical TiBrid™-TC08-0T-3111-708-0T-3111-72026-07-22
00843511102289Omnia Medical TiBrid™-TC08-0T-3112-708-0T-3112-72026-07-22
00843511102296Omnia Medical TiBrid™-TC08-0T-3113-708-0T-3113-72026-07-22
00843511102302Omnia Medical TiBrid™-TC08-0T-3114-708-0T-3114-72026-07-22
00843511102319Omnia Medical TiBrid™-TC08-0T-3115-708-0T-3115-72026-07-22
00843511102326Omnia Medical TiBrid™-TC08-0T-3116-708-0T-3116-72026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843511102135Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102135Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102142Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102142Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102159Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102159Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102166Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102166Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102173Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102173Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102180Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102180Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102197Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102197Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102203Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102203Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102210Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102210Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102227Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102227Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102234Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102234Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102241Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102241Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102258Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102258Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102265Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102265Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22
00843511102272Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102272Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCMAX2026-07-22