Velofix™ PEEK Lumbar Cage

57 catalogue numbers from PLA1410, listed by CG MedTech Co., Ltd., South Korea, under Intervertebral Fusion Device With Bone Graft, Cervical. 7 manufacturers in China are registered for this product code.

Registry build 21.09.26
7manufacturers in China registered for this device type
57catalogue numbers in this listing

Who Else Makes It

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

Chinese manufacturers registered for FDA product code ODP
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
Zhisu Health Tech Jiaxing Co., Ltd. Tongxiang Zhejiang Contract manufacturer 4
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai Shanghai Exporter 106
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Zhejiang Decans Medical Devices Co., Ltd. Jiaxing Zhejiang Manufacturer 10
Shanghai Sanyou Medical Co., Ltd. Shanghai Shanghai Manufacturer 6

Record

Regulatory record for Velofix™ PEEK Lumbar Cage
Listed by CG MedTech Co., Ltd., South Korea
FDA product code ODP
Device type Intervertebral Fusion Device With Bone Graft, Cervical
Device class Class 2
Regulation 21 CFR 888.3080
Establishment Complaint-file establishment, Manufacturer
510(k) K140864
Record published 2016-09-24
Record revised 2025-01-06 (version 8)

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, serial number
Storage Special storage condition: Store in a cool dry place.
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Velofix™ PEEK Lumbar Cage
Catalogue number Size Status
PLA1410 In distribution
PLA2007 In distribution
PLA1811 In distribution
PLA1810 In distribution
PLA1413 In distribution
PLA2414 In distribution
PLA2008 In distribution
PLA1416 In distribution
PLA1007 In distribution
PLA3008 In distribution
PLA1809 In distribution
PLA2813 In distribution
PLA2016 In distribution
PLA2416 In distribution
PLA1813 In distribution
PLA3016 In distribution
PLA3013 In distribution
PLA1814 In distribution
PLA3014 In distribution
PLA2409 In distribution
PLA2810 In distribution
PLA2012 In distribution
PLA3012 In distribution
PLA2814 In distribution
PLA1011 In distribution
PLA1816 In distribution
PLA1412 In distribution
PLA1014 In distribution
PLA1408 In distribution
PLA1010 In distribution
PLA3009 In distribution
PLA3011 In distribution
PLA2812 In distribution
PLA2408 In distribution
PLA2014 In distribution
PLA1812 In distribution
PLA2009 In distribution
PLA1008 In distribution
PLA2010 In distribution
PLA1414 In distribution
PLA2011 In distribution
PLA2811 In distribution
PLA2410 In distribution
PLA2413 In distribution
PLA3007 In distribution
PLA1012 In distribution
PLA2411 In distribution
PLA2013 In distribution
PLA3010 In distribution
PLA2809 In distribution
PLA1409 In distribution
PLA2412 In distribution
PLA1411 In distribution
PLA2816 In distribution
PLA1013 In distribution
PLA1016 In distribution
PLA1009 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Latitude-C AM™ Cervical Interbody Fusion System Degen Medical 1,529
IdentiTi Alphatec Spine, Inc. 1,390
Zavation Zavation 1,357
IVA Cage Ti Diomedical Co., Ltd. 1,202
Latitude-C Cervical Interbody Spacer System Degen Medical 1,185
Peridot Anterior Cervical Intervertebral Body Fusion System Gbs Commonwealth Co., Ltd. 1,056
Aleutian® Interbody Systems VB Spine LLC 1,017
Valeo Spacer System Sintx Technologies Inc. 918
Cascadia™ Interbody System VB Spine LLC 823
CoRoent Nuvasive, Inc. 815
Tyber Medical Tyber Medical 740
Matisse Anterior Cervical Interbody Fusion Cage System CTL Medical Corporation 577

Showing 12 of 938. All products under Intervertebral Fusion Device With Bone Graft, Cervical

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer