What is FDA product code OVD?

Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Omnia Medical TiBrid™-A / SA · Intervertebral Fusion Device with Integrated Fixation, Lumbar → Orthopedic

Name: Omnia Medical TiBrid™-A / SA
Brand: Omnia Medical TiBrid™-A / SA

3manufacturers in China registered for this device type

2catalogue numbers in this listing

2510(k) clearances naming this product code

2recalls on this code

Who Else Makes It

Concentrated in Shandong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OVD
Manufacturer	City	Province	Registered as	Device types
Shandong Weigao Orthopaedic Device Co., Ltd.	Weihai	Shandong	Contract manufacturer	42
Zibo Dante Co., Ltd.	Zibo	Shandong	Contract manufacturer	17
Medtronic (Changzhou) Medical Devices Technology Co., Ltd.	Changzhou	Jiangsu	Manufacturer	53

Record

Regulatory record for Omnia Medical TiBrid™-A / SA
Listed by	Omnia Medical, United States
FDA product code	OVD
Device type	Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device class	Class 2
Regulation	21 CFR 888.3080
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K203207
Record published	2024-05-08

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for Omnia Medical TiBrid™-A / SA
Catalogue number	Size	Status
17-8A-TRY4		In distribution
17-8A-TRY5		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Sirion	Astura Medical	1,465
IdentiTi	Alphatec Spine, Inc.	1,372
EL Capitan	Astura Medical	1,205
Zavation	Zavation	1,157
Brigade	Nuvasive, Inc.	1,005
Solar™ Interbody Fusion System	Degen Medical	899
Zavation F3D Corpectomy	Zavation	730
ROI-A	Ldr Spine USA	552
Avenue L	Ldr Spine USA	524
Transcend Nanotec	Alphatec Spine, Inc.	485
Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology	Titan Spine, LLC	462
Base	Nuvasive, Inc.	462

Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K240623	2024-04-24
K203207	2020-12-23

Recalls Naming This Product

2 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Omnia Medical TiBrid™-A / SA
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Omnia Medical	510(k) number	2024-07-15	Class II	Device Design	Failure of fusion system instruments in the field.	15 units
Omnia Medical	510(k) number	2024-07-15	Class II	Device Design	Failure of fusion system instruments in the field.	15 units

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Omnia Medical TiBrid™-A / SA