FDA.reportPublic FDA data

Omnia Medical TiBrid™-SC

Primary DI
00843511123536
Brand
Omnia Medical TiBrid™-SC
Company
OMNIA MEDICAL, LLC
Model
10-7C-TR16-10
Catalog number
10-7C-TR16-10
Device description
TiBrid™-SC TRIAL WITH STOP, 16.5x14.5x10mm
Published
2024-02-16
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
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212612000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212612000Omnia Medical TiBrid-SCOmnia Medical, LLC2022-11-15OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843511123536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843511123536008435111235368435111235360843511123536

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
Height10Millimeter
Length14.5Millimeter
Width16.5Millimeter

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
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
00810017915125SABER-XA, Screw Ø5.0 x 22.5ELEVATION SPINE, INC.OVE2026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5ELEVATION SPINE, INC.OVE2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.OVE2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.OVE2026-09-22
10888857026551CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2022-06-06
10888857026582CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2022-06-06
07613327506518Anchor CStryker CorporationOVE2019-12-18
10888857027534CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027541CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027558CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027572CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027589CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027596CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027756CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027763CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027770CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027794CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027800CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027817CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
10888857027978CHESAPEAKE® Stabilization SystemVB Spine LLCOVE2018-11-27
04546540679147AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679154AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679161AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679178AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679185AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679192AVS Anchor-CStryker CorporationOVE2016-09-24
04546540679208AVS Anchor-CStryker CorporationOVE2016-09-24
07613252711599AVS Anchor-CStryker CorporationOVE2016-09-24
07613252711605AVS Anchor-CStryker CorporationOVE2016-09-24
07613252711612AVS Anchor-CStryker CorporationOVE2016-09-24