Orthopedic › ProstheticIntervertebral Fusion Device With Bone Graft, Lumbar

Valeo II AL Interbody Fusion System

VALEO II AL 39x30 10mm 12 deg

Registry build 21.09.26
14manufacturers in China registered for this device type
62catalogue numbers in this listing
4510(k) clearances naming this product code
4recalls on this code

Who Else Makes It

Concentrated in Jiangsu (6), Shandong (2), Shanghai (2). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code MAX
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Zibo Dante Co., Ltd. Zibo Shandong Contract manufacturer 17
Jiangsu Ideal Medical Science & Technology Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 7
Zhisu Health Tech Jiaxing Co., Ltd. Tongxiang Zhejiang Contract manufacturer 4
Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Changzhou Jiangsu Manufacturer 53
Shanghai Reach Medical Instrument Co., Ltd. Shanghai Shanghai Manufacturer 30
Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. Changzhou Jiangsu Contract manufacturer 25
Double Medical Technology Inc. Xiamen Fujian Contract manufacturer 14
Zhejiang Decans Medical Devices Co., Ltd. Jiaxing Zhejiang Manufacturer 10

Showing 12 of 14. All 14 manufacturers in China registered for Intervertebral Fusion Device With Bone Graft, Lumbar

Record

Regulatory record for Valeo II AL Interbody Fusion System
Listed by CTL Medical Corporation, United States
FDA product code MAX
Device type Intervertebral Fusion Device With Bone Graft, Lumbar
Device class Class 2
Regulation 21 CFR 888.3080
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k) K082801
Record published 2023-09-20
Record revised 2026-06-17 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Valeo II AL Interbody Fusion System
Catalogue number Size Status
11.016.6410 In distribution
11.016.4123 In distribution
11.016.6409 In distribution
11.016.4120 In distribution
11.016.5121 In distribution
11.016.5417 In distribution
11.016.6420 In distribution
11.016.5414 In distribution
11.016.6809 In distribution
11.016.4122 In distribution
11.016.4815 In distribution
11.016.4811 In distribution
11.016.6810 In distribution
11.016.6815 In distribution
11.016.5122 In distribution
11.016.4121 In distribution
11.016.4422 In distribution
11.016.4414 In distribution
11.016.4415 In distribution
11.016.6417 In distribution
11.016.5813 In distribution
11.016.5415 In distribution
11.016.5812 In distribution
11.016.4817 In distribution
11.016.4814 In distribution
11.016.5412 In distribution
11.016.6813 In distribution
11.016.6415 In distribution
11.016.5127 In distribution
11.016.5410 In distribution
11.016.6416 In distribution
11.016.6412 In distribution
11.016.6419 In distribution
11.016.4127 In distribution
11.016.5815 In distribution
11.016.5413 In distribution
11.016.5811 In distribution
11.016.6413 In distribution
11.016.6812 In distribution
11.016.4810 In distribution
11.016.6411 In distribution
11.016.4417 In distribution
11.016.6414 In distribution
11.016.5411 In distribution
11.016.4124 In distribution
11.016.5123 In distribution
11.016.4125 In distribution
11.016.6811 In distribution
11.016.4412 In distribution
11.016.4411 In distribution
11.016.5810 In distribution
11.016.5814 In distribution
11.016.5120 In distribution
11.016.4413 In distribution
11.016.6418 In distribution
11.016.6814 In distribution
11.016.4813 In distribution
11.016.5125 In distribution
11.016.5124 In distribution
11.016.4410 In distribution
11.016.4812 In distribution
11.016.5817 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Peridot Intervertebral body fusion system Gbs Commonwealth Co., Ltd. 10,850
Yellowstone Summit Spine 6,654
CoRoent Nuvasive, Inc. 5,690
Zavation Zavation 2,554
Anyplus II Spinal Fixation System GS Medical Co., Ltd. 2,533
Talos® IBF Meditech Spine, LLC 2,163
Peridot-PT Intervertebral body fusion system Gbs Commonwealth Co., Ltd. 1,956
TirboLOX-L Lumbar Ibfd Captiva Spine, Inc. 1,926
Endoskeleton® TL Titan Spine, LLC 1,896
Evos Lumbar Interbody System Cutting Edge Spine 1,871
Epiphany Pantheon Spinal LLC 1,507
LnK Lumbar Interbody Fusion Cage System L&K Biomed Co., Ltd. 1,506

Showing 12 of 1,958. All products under Intervertebral Fusion Device With Bone Graft, Lumbar

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K233947 2024-10-10
K231359 2023-06-09
K213641 2022-09-15
K192863 2020-08-26

Recalls

4 of these are 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
2019-08-21 Class II Device Design Reports received of the device fracturing during insertion. 46 units
2019-08-21 Class II Device Design Reports received of the device fracturing during insertion. 45 units
2019-08-21 Class II Device Design Reports received of the device fracturing during insertion. 39 units
2019-08-21 Class II Device Design Reports received of the device fracturing during insertion. 39 units

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number Decision Trade name Approved to
P000028 2004-06-18 AFFINITY ANTERIOR CERVICAL CAGE SYSTEM Medtronic Sofamor Danek USA, Inc.
P970015 2003-09-10 LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE Sofamor Danek
P980048 2001-04-20 BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM Sulzer Spine-Tech
P950019 1999-03-19 RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION Stryker Spine
P950002 1997-06-30 BAK INTERBODY FUSION SYSTEM Zimmer Spine, Inc.

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