FDA.reportPublic FDA data

Omnia Medical VBR

Primary DI
00843511101107
Brand
Omnia Medical VBR
Company
OMNIA MEDICAL, LLC
Model
06-5V-TR49
Catalog number
06-5V-TR49
Device description
49mm Omnia Medical VBR Trial
Published
2020-03-31
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
MQPSpinal Vertebral Body Replacement Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172323000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172323000Omnia Medical VBROmnia Medical, LLC2017-10-26MQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843511101107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843511101107008435111011078435111011070843511101107

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height49Millimeter

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
00843511102579Omnia Medical TiBrid™-TS09-0P-102207-102026-07-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18257200151271CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151288CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151295CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151325CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151349CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151356CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151363CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151370CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151387CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151394CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151424CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151431CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151448CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151455CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151462CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151479CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151493CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151509CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151523CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151530CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151547CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151561CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151578CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151585CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151592CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151608CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151615CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151622CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151639CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17
18257200151646CONSTRUX - MINI PEEK VBROrthofix US LLCMQP2026-07-17