Who else makes this device?

Name: Endoskeleton® TA VBR Sterile Barrier System
Brand: Endoskeleton® TA VBR Sterile Barrier System

Endoskeleton® TA VBR Sterile Barrier System · Spinal Vertebral Body Replacement Device → Orthopedic

3manufacturers in China registered for this device type

6catalogue numbers in this listing

1recall

Who Else Makes It

Concentrated in Shanghai (1), Jiangsu (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code MQP
Manufacturer	City	Province	Registered as	Device types
Shandong Weigao Orthopaedic Device Co., Ltd.	Weihai	Shandong	Contract manufacturer	42
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Medtronic (Changzhou) Medical Devices Technology Co., Ltd.	Changzhou	Jiangsu	Manufacturer	53

Record

Regulatory record for Endoskeleton® TA VBR Sterile Barrier System
Listed by	Titan Spine, LLC, United States
FDA product code	MQP
Device type	Spinal Vertebral Body Replacement Device
Device class	Class 2
Regulation	21 CFR 888.3060
Record published	2016-12-15
Record revised	2025-07-14 (version 10)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Sizes	Width 32 to 40 mm; depth 21 to 27 mm; angle 7 °; height 18 to 20 mm
Distribution end date	2020-09-18
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Endoskeleton® TA VBR Sterile Barrier System
Catalogue number	Size	Status
2107-0118-S	Width 32 mm	Withdrawn
2107-0320-S	width(MLxAP), 40 x 27, mm	Withdrawn
2107-0220-S	Width 36 mm	Withdrawn
2107-0120-S	Angle 7 °	Withdrawn
2107-0318-S	Width 40 mm	Withdrawn
2107-0218-S	Depth 24 mm	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
CoRoent	Nuvasive, Inc.	1,514
Capri™ Corpectomy Cage System	VB Spine LLC	1,509
Aleutian® Interbody Systems	VB Spine LLC	1,189
Fortify	Globus Medical, Inc.	866
Matrixx System	Nexxt Spine LLC	748
Ascend	Alphatec Spine, Inc.	555
Zavation VBR Trial	Zavation	548
Verte-Stack® Spinal System	Medtronic Sofamor Danek, Inc.	484
Timberline® Lateral Interbody Fusion System	Biomet Spine	470
Timberline Lateral Fusion System	Biomet Spine	459
Novel	Alphatec Spine, Inc.	447
Hawkeye™ Vertebral Body Replacement (VBR)	Choice Spine, LP	368

Showing 12 of 683. All products under Spinal Vertebral Body Replacement Device

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2012-10-19	Class II	Labeling False and Misleading	Titan Spine LLC, is conducting a recall on the Endoskeleton TA VBR products. The labeling accompanying this device contains incorrect indications for use.	92 pcs.	2013-01-14

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.

Endoskeleton® TA VBR Sterile Barrier System