Orthopedic › ProstheticIntervertebral Fusion Device With Bone Graft, Cervical

Valeo C Spacer System

VALEO C 17x14 12mm 6 deg TEXTURED

Registry build 21.09.26
7manufacturers in China registered for this device type
106catalogue numbers in this listing
4510(k) clearances naming this product code

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 Valeo C Spacer System
Listed by CTL Medical Corporation, United States
FDA product code ODP
Device type Intervertebral Fusion Device With Bone Graft, Cervical
Device class Class 2
Regulation 21 CFR 888.3080
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k) K091278
Record published 2023-09-30
Record revised 2026-06-19 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Valeo C Spacer System
Catalogue number Size Status
91.002.2408 In distribution
11.009.2009 In distribution
11.009.2005 In distribution
11.009.2612 In distribution
91.002.3106 In distribution
91.002.3306 In distribution
91.002.2208 In distribution
91.002.3411 In distribution
91.002.2210 In distribution
11.009.2010 In distribution
91.002.3109 In distribution
91.002.3108 In distribution
91.002.3212 In distribution
91.002.4007 In distribution
11.009.2008 In distribution
91.002.3210 In distribution
11.009.2012 In distribution
91.002.2309 In distribution
11.009.1608 In distribution
11.009.1012 In distribution
91.002.2205 In distribution
11.009.2606 In distribution
91.002.3112 In distribution
91.002.2306 In distribution
91.002.2209 In distribution
91.002.3408 In distribution
91.002.3105 In distribution
91.002.3206 In distribution
11.009.1610 In distribution
11.009.2607 In distribution
91.002.2105 In distribution
91.002.3107 In distribution
91.002.2111 In distribution
91.002.3309 In distribution
91.002.4106 In distribution
91.002.2207 In distribution
91.002.2106 In distribution
91.002.2307 In distribution
91.002.4107 In distribution
91.002.2308 In distribution
91.002.2407 In distribution
91.002.3211 In distribution
91.002.3410 In distribution
91.002.3310 In distribution
91.002.2108 In distribution
91.002.2405 In distribution
91.002.2410 In distribution
11.002.1609 In distribution
11.009.1611 In distribution
11.009.1009 In distribution
11.009.2610 In distribution
11.009.1609 In distribution
91.002.3409 In distribution
11.002.1608 In distribution
91.002.3110 In distribution
91.002.2112 In distribution
91.002.4003 In distribution
91.002.3405 In distribution
11.009.2605 In distribution
91.002.3207 In distribution
11.009.1605 In distribution
11.002.2608 In distribution
91.002.2312 In distribution
11.009.1011 In distribution
91.002.2107 In distribution
11.009.1010 In distribution
91.002.4001 In distribution
11.009.1612 In distribution
91.002.3205 In distribution
91.002.3311 In distribution
11.009.1007 In distribution
91.002.3412 In distribution
11.009.1006 In distribution
91.002.3111 In distribution
11.009.2609 In distribution
91.002.2110 In distribution
91.002.2109 In distribution
91.002.4006 In distribution
11.009.2608 In distribution
91.002.2409 In distribution
91.002.2311 In distribution
91.002.3209 In distribution
91.002.3406 In distribution
91.002.2406 In distribution
91.002.3407 In distribution
91.002.3307 In distribution
91.002.2211 In distribution
91.002.2412 In distribution
91.002.4002 In distribution
11.009.1008 In distribution
91.002.3208 In distribution
91.002.2305 In distribution
91.002.3305 In distribution
11.009.2611 In distribution
91.002.2411 In distribution
11.009.1607 In distribution
11.009.2007 In distribution
91.002.2212 In distribution
11.009.2011 In distribution
11.009.1606 In distribution
91.002.3312 In distribution
91.002.2310 In distribution
91.002.3308 In distribution
11.009.2006 In distribution
91.002.2206 In distribution
11.009.1005 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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K220513 2023-04-25
K172788 2018-06-25
K172212 2018-01-09
K162682 2017-06-01

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