What is FDA product code OVE?

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

MSB Titan TL Interbody · Intervertebral Fusion Device with Integrated Fixation, Cervical → Orthopedic

Name: MSB Titan TL Interbody
Brand: MSB Titan TL Interbody

5manufacturers in China registered for this device type

2catalogue numbers in this listing

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Zhejiang (2), Guangdong (1), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OVE
Manufacturer	City	Province	Registered as	Device types
Apex (Guangzhou) Tools & Orthopedics Company	Guangzhou	Guangdong	Contract manufacturer	62
Zibo Dante Co., Ltd.	Zibo	Shandong	Contract manufacturer	17
Zhisu Health Tech Jiaxing Co., Ltd.	Tongxiang	Zhejiang	Contract manufacturer	4
Medtronic (Changzhou) Medical Devices Technology Co., Ltd.	Changzhou	Jiangsu	Manufacturer	53
Zhejiang Decans Medical Devices Co., Ltd.	Jiaxing	Zhejiang	Manufacturer	10

Record

Regulatory record for MSB Titan TL Interbody
Listed by	Medtronic Sofamor Danek, Inc., United States
FDA product code	OVE
Device type	Intervertebral Fusion Device With Integrated Fixation, Cervical
Device class	Class 2
Regulation	21 CFR 888.3080
510(k)	K151596
Record published	2026-06-15

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for MSB Titan TL Interbody
Catalogue number	Size	Status
5301-3814		In distribution
5301-3513		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
IdentiTi	Alphatec Spine, Inc.	630
Dolomite	Astura Medical	607
CoRoent	Nuvasive, Inc.	580
Aeon-C	Diomedical Co., Ltd.	508
Tomcat™ Cervical Spinal System	Choice Spine, LP	468
Shoreline ACS	Seaspine Orthopedics Corporation	428
Zavation	Zavation	423
Alta™ Stand-Alone Interbody Fusion System	Biomet Spine	404
Unison™-C Anterior Cervical Fixation System	Pioneer Surgical Technology, Inc.	334
Chesapeake® Stabilization System	VB Spine LLC	272
UniSpace® Stand-Alone C Cage	CG MedTech Co., Ltd.	260
Solitaire-C Cervical Spacer	Biomet Spine	256

Showing 12 of 391. All products under Intervertebral Fusion Device With Integrated Fixation, Cervical

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K113252	2012-01-17
K094042	2010-06-30

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of MSB Titan TL Interbody
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Medtronic Sofamor Danek USA, Inc.	510(k) number	2021-09-02	Class II	Packaging change control	Engraving on implants may not match what is listed on the pouch labels.	9 units	2023-10-05

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.

MSB Titan TL Interbody