Who else makes this device?

Name: Colosseum
Brand: Colosseum

Colosseum · Spinal Vertebral Body Replacement Device → Orthopedic

3manufacturers in China registered for this device type

91catalogue numbers in this listing

11510(k) clearances naming this product code

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 Colosseum
Listed by	Globus Medical, Inc., United States
FDA product code	MQP
Device type	Spinal Vertebral Body Replacement Device
Device class	Class 2
Regulation	21 CFR 888.3060
Establishment	Manufacturer, Exporter
510(k)	K190147
Record published	2019-12-27
Record revised	2025-07-14 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Single use	Yes
Latex	Contains natural rubber latex
Label carries	lot or batch number
Sizes	Height 2 to 148 mm; width 14 to 30 mm; depth 12 to 25 mm; angle 3.5 to 12 °; depth 14 µm

Catalogue Numbers

Catalogue numbers for Colosseum
Catalogue number	Size	Status
156.704	Height 16 mm	In distribution
156.720	Depth 21 mm	In distribution
156.764	Width 23 mm	In distribution
156.209	Depth 12 mm	In distribution
156.376	Angle 8 °	In distribution
156.982	Depth 25 mm	In distribution
156.711	Depth 21 mm	In distribution
156.232	Width 14 mm	In distribution
156.303	Width 16 mm	In distribution
156.210	Width 14 mm	In distribution
156.456	Depth 15 mm	In distribution
156.409	Height 36 mm	In distribution
156.737	Depth 21 mm	In distribution
156.404	Width 18 mm	In distribution
156.762	Height 4 mm	In distribution
156.766	Height 8 mm	In distribution
156.964	Height 6 mm	In distribution
156.756	Width 23 mm	In distribution
156.564	Height 4 mm	In distribution
156.454	Depth 15 mm	In distribution
156.553	Width 16 mm	In distribution
156.406	Height 24 mm	In distribution
156.563	Angle 3.5 °	In distribution
156.226	Width 14 mm	In distribution
156.920	Depth 25 mm	In distribution
156.275	Depth 12 mm	In distribution
156.705	Depth 21 mm	In distribution
156.208	Depth 12 mm	In distribution
156.915	Depth 25 mm	In distribution
156.305	Height 20 mm	In distribution
156.231	Depth 12 mm	In distribution
156.903	Depth 25 mm	In distribution
156.263	Height 3 mm	In distribution
156.227	Depth 12 mm	In distribution
156.976	Width 30 mm	In distribution
156.430	Height 120 mm	In distribution
156.702	Width 23 mm	In distribution
156.774	Width 23 mm	In distribution
156.312	Depth 16 mm	In distribution
156.912	Width 30 mm	In distribution
156.320	Depth 16 mm	In distribution
156.364	Depth 16 mm	In distribution
156.420	Width 18 mm	In distribution
156.330	Depth 16 mm	In distribution
156.415	Height 60 mm	In distribution
156.309	Height 36 mm	In distribution
156.532	Height 48 mm	In distribution
156.530	Height 40 mm	In distribution
156.507	Width 16 mm	In distribution
656.104		In distribution
156.403	Width 18 mm	In distribution
156.266	Width 14 mm	In distribution
156.236	Depth 12 mm	In distribution
156.956	Depth 25 mm	In distribution
156.752	Depth 21 mm	In distribution
156.203	Depth 12 mm	In distribution
156.952	Depth 25 mm	In distribution
156.911	Depth 25 mm	In distribution
156.411	Width 18 mm	In distribution
156.715	Depth 21 mm	In distribution
156.466	Width 18 mm	In distribution
156.548	Depth 14 mm	In distribution
156.908	Depth 25 mm	In distribution
656.105		In distribution
156.464	Depth 15 mm	In distribution
156.206	Width 14 mm	In distribution
156.274	Angle 7 °	In distribution
156.503	Depth 14 mm	In distribution
156.502	Depth 14 mm	In distribution
156.754	Depth 21 mm	In distribution
156.273	Angle 7 °	In distribution
156.703	Height 12 mm	In distribution
156.505	Depth 14 mm	In distribution
156.254	Height 4 mm	In distribution
156.512	Depth 14 µm	In distribution
156.986	Depth 25 mm	In distribution
156.276	Width 14 mm	In distribution
156.708	Height 32 mm	In distribution
156.529	Height 36 mm	In distribution
156.374	Width 16 mm	In distribution
156.565	Depth 14 mm	In distribution
656.102		In distribution
156.253	Width 14 mm	In distribution
156.354	Depth 16 mm	In distribution
156.573	Height 3 mm	In distribution
156.230	Width 14 mm	In distribution
156.215	Height 60 mm	In distribution
156.352	Width 16 mm	In distribution
156.462	Width 18 mm	In distribution
156.772	Height 4 mm	In distribution
156.362	Height 4 mm	In distribution

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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K190147	2019-05-08
K173982	2018-09-19
K162315	2017-11-09
K121107	2012-07-03
K112756	2011-10-07
K072465	2007-10-04
K061380	2006-06-08
K060665	2006-05-10
K050850	2005-05-26
K040284	2004-03-23
K031302	2003-06-27

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.

Colosseum