Orthopedic › ProstheticIntervertebral Fusion Device With Bone Graft, Lumbar

Altus Spine Interbody Fusion System

18/22mm Parallel Sizer Left Parallel

Registry build 21.09.26
14manufacturers in China registered for this device type
114catalogue numbers in this listing

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 Altus Spine Interbody Fusion System
Listed by Altus Spine, United States
FDA product code MAX
Device type Intervertebral Fusion Device With Bone Graft, Lumbar
Device class Class 2
Regulation 21 CFR 888.3080
510(k) K170553
Record published 2018-09-25
Record revised 2024-09-11 (version 4)

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 4 to 18 mm; length 16 to 30 mm

Catalogue Numbers

Catalogue numbers for Altus Spine Interbody Fusion System
Catalogue number Size Status
1000-1816L Height 16 mm In distribution
722-1006 Height 6 mm In distribution
1000-0040 Height 12 mm In distribution
1000-1814L Height 14 mm In distribution
722-2016 Height 16 mm In distribution
730-0010 Height 10 mm In distribution
1001-3012 Height 12 mm In distribution
1000-0300B In distribution
1000-3012 Height 12 mm In distribution
1000-1810 Height 10 mm In distribution
1000-2614 Height 14 mm In distribution
1000-1604 Height 4 mm In distribution
1000-2214 Height 14 mm In distribution
730-0013 Height 13 mm In distribution
722-1015 Height 15 mm In distribution
1000-2210L Height 10 mm In distribution
722-2017 Height 17 mm In distribution
1001-3010 Height 10 mm In distribution
730-0009 Height 9 mm In distribution
1001-2210 Height 10 mm In distribution
722-1018 Height 18 mm In distribution
1000-0300SB In distribution
1001-1814 Height 14 mm In distribution
1000-1816 Height 16 mm In distribution
790-0007 Height 7 mm In distribution
790-0014 Height 14 mm In distribution
1001-3014 Height 14 mm In distribution
730-0012 Height 12 mm In distribution
1000-2206 Height 6 mm In distribution
722-2009 Height 9 mm In distribution
722-2007 Height 7 mm In distribution
722-1013 Height 13 mm In distribution
1000-1808 Height 8 mm In distribution
1000-3008 Height 8 mm In distribution
780-0021 In distribution
1000-1812L Height 12 mm In distribution
1000-3006 Length 30 mm In distribution
1000-3014 Height 14 mm In distribution
730-0014 Height 14 mm In distribution
722-1014 Height 14 mm In distribution
722-1007 Height 7 mm In distribution
1000-2206B Length 22 mm In distribution
1000-1812 Height 12 mm In distribution
722-2006 Height 6 mm In distribution
1001-2612 Height 12 mm In distribution
1001-3016 Height 16 mm In distribution
722-1016 Height 16 mm In distribution
1001-2608 Height 8 mm In distribution
1000-2610 Height 10 mm In distribution
1000-0038 Height 10 mm In distribution
1000-2208L Height 8 mm In distribution
1000-1806B Height 6 mm In distribution
1000-2608 Height 8 mm In distribution
1000-2212 Height 12 mm In distribution
1000-3016 Height 16 mm In distribution
722-2012 Height 12 mm In distribution
790-0008 Height 8 mm In distribution
722-1011 Height 11 mm In distribution
1000-2612 Height 12 mm In distribution
1001-3008 Height 8 mm In distribution
1000-3006B Length 30 mm In distribution
1001-1816 Height 16 mm In distribution
1000-1810L Height 10 mm In distribution
790-0013 Height 13 mm In distribution
1000-3010 Height 10 mm In distribution
722-2014 Height 14 mm In distribution
790-0001 In distribution
1000-2212L Height 12 mm In distribution
780-0001 In distribution
1000-2208 Height 8 mm In distribution
790-0016 Height 16 mm In distribution
790-0010 Height 10 mm In distribution
1000-2210 Height 10 mm In distribution
1000-0300S In distribution
1000-2214L Height 14 mm In distribution
1001-2216 Height 16 mm In distribution
730-0011 Height 11 mm In distribution
790-0011 Height 11 mm In distribution
1000-1806 Length 18 mm In distribution
790-0009 Height 9 mm In distribution
1000-0300 In distribution
722-2018 Height 18 mm In distribution
722-1008 Height 8 mm In distribution
790-0015 Height 15 mm In distribution
1000-2216 Height 16 mm In distribution
722-1010 Height 10 mm In distribution
1000-2606B Height 6 mm In distribution
722-1009 Height 9 mm In distribution
1000-1814 Height 14 mm In distribution
1001-1812 Height 12 mm In distribution
722-2008 Height 8 mm In distribution
1001-2208 Height 8 mm In distribution
1000-2616 Height 16 mm In distribution
1001-2610 Height 10 mm In distribution
1001-2616 Height 16 mm In distribution
1001-2614 Height 14 mm In distribution
1001-1808 Height 8 mm In distribution
1001-1810 Height 10 mm In distribution
1000-2606 Height 6 mm In distribution
722-1012 Height 12 mm In distribution
1001-2212 Height 12 mm In distribution
1000-0042 Height 14 mm In distribution
722-2015 Height 15 mm In distribution
722-2010 Height 10 mm In distribution
730-0005 In distribution
1000-1808L Height 8 mm In distribution
722-2013 Height 13 mm In distribution
790-0012 Height 12 mm In distribution
1001-2214 Height 14 mm In distribution
730-0015 Height 15 mm In distribution
1000-2216L Height 16 mm In distribution
790-0006 Height 6 mm In distribution
722-1017 Height 17 mm In distribution
722-2011 Height 11 mm 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

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