Who else makes this device?

Name: Endoskeleton TA VBR
Brand: Endoskeleton TA VBR

Endoskeleton TA VBR · Spinal Vertebral Body Replacement Device → Orthopedic

3manufacturers in China registered for this device type

23catalogue 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
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
510(k)	K032812
Record published	2016-09-17
Record revised	2022-09-16 (version 12)

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, manufacturing date
Sizes	Height 16 to 20 mm; depth 21 to 27 mm; angle 7 °; width 32 to 40 mm; length 8 in; height 1.5 in; width 5 in
Distribution end date	2020-09-21
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Endoskeleton TA VBR
Catalogue number	Size	Status
2156-7218	Height 18 mm	Withdrawn
2156-9217	Height 17 mm	Withdrawn
2156-7220	Lordotic Angle 7 Deg	Withdrawn
2156-9119	Angle 7 °	Withdrawn
2200-0001	Length 8 in	Withdrawn
2200-0001	Length 8 in	Withdrawn
2156-9218	Height 18 mm	Withdrawn
2156-7120	Lordotic Angle 7 Deg	Withdrawn
2156-9219	Depth 24 mm	Withdrawn
2156-9317	Angle 7 °	Withdrawn
2156-9220	Lordotic Angle 7 Deg	Withdrawn
2156-9216	Height 16 mm	Withdrawn
2156-9116	Lordotic Angle 7 Deg	Withdrawn
2156-9320	Lordotic Angle 7 Deg	Withdrawn
2156-9316	width(MLxAP), 40 x 27, mm	Withdrawn
2107-0318	Width 40 mm	Withdrawn
2156-9120	Height 20 mm	Withdrawn
2156-9319	Width 40 mm	Withdrawn
2156-7118	Lordotic Angle 7 Deg	Withdrawn
2156-9318	Angle 7 °	Withdrawn
2156-9118	Height 18 mm	Withdrawn
2156-9117	Angle 7 °	Withdrawn
2107-0320	Depth 27 mm	Withdrawn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 Naming This Product

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

Recalls naming the identifiers of Endoskeleton TA VBR
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Titan Spine, LLC	510(k) number	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