Squadron Lumbar Cage
Squadron Anatomical Bullet Nose PLIF Cage, 20mm x 10mm x 10mm
14manufacturers in China registered for this device type
612catalogue 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.
| 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
| Listed by | Valorus Spine, LLC, 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 | Manufacturer |
| 510(k) | K171914 |
| Record published | 2023-07-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 31-01-321108 | In distribution | |
| 31-03-251208 | In distribution | |
| 31-02-201214 | In distribution | |
| 31-03-251108 | In distribution | |
| 38-01-300510 | In distribution | |
| 31-01-250915 | In distribution | |
| 31-03-201010 | In distribution | |
| 31-02-301015 | In distribution | |
| 31-01-281213 | In distribution | |
| 31-01-250908 | In distribution | |
| 31-03-200912 | In distribution | |
| 38-01-280514 | In distribution | |
| 31-02-281212 | In distribution | |
| 31-01-301011 | In distribution | |
| 31-02-321209 | In distribution | |
| 31-02-201107 | In distribution | |
| 31-02-250908 | In distribution | |
| 31-03-251109 | In distribution | |
| 31-03-320908 | In distribution | |
| 31-02-300909 | In distribution | |
| 38-01-300012 | In distribution | |
| 31-02-201014 | In distribution | |
| 38-01-300513 | In distribution | |
| 31-01-201108 | In distribution | |
| 31-01-320912 | In distribution | |
| 31-01-320913 | In distribution | |
| 31-03-301012 | In distribution | |
| 31-03-201008 | In distribution | |
| 31-03-300909 | In distribution | |
| 31-03-301014 | In distribution | |
| 31-01-201113 | In distribution | |
| 31-01-281010 | In distribution | |
| 31-03-321013 | In distribution | |
| 31-02-321111 | In distribution | |
| 31-02-321008 | In distribution | |
| 31-03-300908 | In distribution | |
| 31-01-281209 | In distribution | |
| 31-02-251215 | In distribution | |
| 38-01-300507 | In distribution | |
| 38-01-300015 | In distribution | |
| 31-02-201208 | In distribution | |
| 31-03-301215 | In distribution | |
| 31-01-250912 | In distribution | |
| 31-02-250910 | In distribution | |
| 38-01-320510 | In distribution | |
| 31-02-281112 | In distribution | |
| 31-02-301207 | In distribution | |
| 31-01-250913 | In distribution | |
| 31-02-281209 | In distribution | |
| 31-03-321207 | In distribution | |
| 31-02-200915 | In distribution | |
| 31-02-251213 | In distribution | |
| 31-02-301108 | In distribution | |
| 31-03-251113 | In distribution | |
| 31-02-300907 | In distribution | |
| 31-03-321014 | In distribution | |
| 31-02-280914 | In distribution | |
| 31-01-281214 | In distribution | |
| 31-01-280910 | In distribution | |
| 31-01-321109 | In distribution | |
| 31-02-300915 | In distribution | |
| 31-02-281208 | In distribution | |
| 31-01-301013 | In distribution | |
| 31-03-201112 | In distribution | |
| 31-03-250907 | In distribution | |
| 38-01-280509 | In distribution | |
| 31-02-201113 | In distribution | |
| 31-02-300912 | In distribution | |
| 31-01-281115 | In distribution | |
| 31-03-251011 | In distribution | |
| 38-01-320515 | In distribution | |
| 31-03-281009 | In distribution | |
| 38-01-260512 | In distribution | |
| 31-02-201209 | In distribution | |
| 31-03-301109 | In distribution | |
| 31-03-281112 | In distribution | |
| 38-01-280011 | In distribution | |
| 31-02-301113 | In distribution | |
| 31-01-320911 | In distribution | |
| 31-03-200915 | In distribution | |
| 31-01-321009 | In distribution | |
| 38-01-300508 | In distribution | |
| 31-02-321108 | In distribution | |
| 31-02-250912 | In distribution | |
| 31-02-320908 | In distribution | |
| 31-01-321015 | In distribution | |
| 31-02-251214 | In distribution | |
| 31-03-321012 | In distribution | |
| 31-03-301112 | In distribution | |
| 31-03-201115 | In distribution | |
| 31-02-250907 | In distribution | |
| 31-03-201114 | In distribution | |
| 38-01-260008 | In distribution | |
| 31-03-301209 | In distribution | |
| 31-01-200907 | In distribution | |
| 31-01-280909 | In distribution | |
| 31-03-281008 | In distribution | |
| 31-01-201214 | In distribution | |
| 31-02-251108 | In distribution | |
| 31-01-201215 | In distribution | |
| 31-03-250908 | In distribution | |
| 31-02-301115 | In distribution | |
| 31-02-281207 | In distribution | |
| 31-02-251210 | In distribution | |
| 31-02-250911 | In distribution | |
| 38-01-320508 | In distribution | |
| 31-02-320915 | In distribution | |
| 31-03-321008 | In distribution | |
| 31-02-201108 | In distribution | |
| 31-03-281109 | In distribution | |
| 31-01-201207 | In distribution | |
| 31-02-321110 | In distribution | |
| 38-01-300511 | In distribution | |
| 31-02-321007 | In distribution | |
| 31-03-321010 | In distribution | |
| 31-02-250913 | In distribution | |
| 38-01-280515 | In distribution | |
| 31-01-251014 | In distribution | |
| 31-01-301213 | In distribution | |
| 31-02-251012 | In distribution | |
| 31-02-301208 | In distribution | |
| 31-03-321108 | In distribution | |
| 31-01-321209 | In distribution | |
| 31-03-320912 | In distribution | |
| 38-01-280008 | In distribution | |
| 31-01-280915 | In distribution | |
| 31-03-321212 | In distribution | |
| 31-01-251209 | In distribution | |
| 31-01-250911 | In distribution | |
| 31-03-321009 | In distribution | |
| 31-02-280909 | In distribution | |
| 31-03-200913 | In distribution | |
| 31-02-201115 | In distribution | |
| 31-03-250914 | In distribution | |
| 31-02-301212 | In distribution | |
| 31-03-321007 | In distribution | |
| 31-03-201011 | In distribution | |
| 31-01-300911 | In distribution | |
| 31-01-300908 | In distribution | |
| 31-02-281014 | In distribution | |
| 31-01-251013 | In distribution | |
| 31-01-301211 | In distribution | |
| 31-02-251010 | In distribution | |
| 31-01-301009 | In distribution | |
| 31-03-321015 | In distribution | |
| 31-02-321114 | In distribution | |
| 31-03-200909 | In distribution | |
| 38-01-260510 | In distribution | |
| 31-02-281115 | In distribution | |
| 31-03-321215 | In distribution | |
| 38-01-300514 | In distribution | |
| 31-01-200908 | In distribution | |
| 31-03-301210 | In distribution | |
| 38-01-260513 | In distribution | |
| 31-01-251207 | In distribution | |
| 31-03-251013 | In distribution | |
| 31-01-280907 | In distribution | |
| 38-01-320011 | In distribution | |
| 31-01-201110 | In distribution | |
| 31-02-321113 | In distribution | |
| 31-02-281113 | In distribution | |
| 31-02-251008 | In distribution | |
| 31-03-321214 | In distribution | |
| 31-03-321209 | In distribution | |
| 31-02-200910 | In distribution | |
| 31-03-301015 | In distribution | |
| 31-02-201213 | In distribution | |
| 38-01-300010 | In distribution | |
| 31-03-251107 | In distribution | |
| 31-03-201213 | In distribution | |
| 31-02-321010 | In distribution | |
| 31-01-201107 | In distribution | |
| 31-03-301007 | In distribution | |
| 31-01-301108 | In distribution | |
| 31-01-301107 | In distribution | |
| 31-03-281211 | In distribution | |
| 31-03-281207 | In distribution | |
| 31-03-320907 | In distribution | |
| 31-01-321008 | In distribution | |
| 31-03-251211 | In distribution | |
| 38-01-280007 | In distribution | |
| 31-03-201207 | In distribution | |
| 31-02-321011 | In distribution | |
| 31-01-321211 | In distribution | |
| 31-01-251107 | In distribution | |
| 31-02-251014 | In distribution | |
| 31-02-301213 | In distribution | |
| 31-03-321110 | In distribution | |
| 31-01-281113 | In distribution | |
| 31-01-280912 | In distribution | |
| 31-01-321111 | In distribution | |
| 31-02-201015 | In distribution | |
| 31-03-280911 | In distribution | |
| 31-01-201109 | In distribution | |
| 31-02-320909 | In distribution | |
| 31-02-251011 | In distribution | |
| 31-02-281213 | In distribution | |
| 31-01-281011 | In distribution | |
| 31-02-321210 | In distribution | |
| 31-02-251110 | In distribution | |
| 31-03-301110 | In distribution | |
| 31-02-321211 | In distribution | |
| 31-02-281108 | In distribution | |
| 31-03-251014 | In distribution | |
| 31-03-251115 | In distribution | |
| 31-02-321013 | In distribution | |
| 31-01-201111 | In distribution | |
| 31-02-300908 | In distribution | |
| 31-03-251209 | In distribution | |
| 31-01-301112 | In distribution | |
| 31-03-251015 | In distribution | |
| 31-02-321014 | In distribution | |
| 31-01-320914 | In distribution | |
| 31-02-251115 | In distribution | |
| 31-02-320914 | In distribution | |
| 31-03-301010 | In distribution | |
| 31-02-301109 | In distribution | |
| 31-02-321015 | In distribution | |
| 31-01-321208 | In distribution | |
| 38-01-260011 | In distribution | |
| 31-01-281208 | In distribution | |
| 31-02-200914 | In distribution | |
| 31-03-281007 | In distribution | |
| 31-03-281012 | In distribution | |
| 31-03-321211 | In distribution | |
| 31-03-300911 | In distribution | |
| 38-01-260514 | In distribution | |
| 31-03-301107 | In distribution | |
| 31-02-251007 | In distribution | |
| 31-01-251008 | In distribution | |
| 31-02-301114 | In distribution | |
| 31-03-300913 | In distribution | |
| 31-03-251008 | In distribution | |
| 38-01-260015 | In distribution | |
| 31-01-201114 | In distribution | |
| 31-03-201208 | In distribution | |
| 31-01-200915 | In distribution | |
| 31-01-301015 | In distribution | |
| 31-01-301212 | In distribution | |
| 38-01-300013 | In distribution | |
| 31-03-250909 | In distribution | |
| 31-01-201211 | In distribution | |
| 31-03-201215 | In distribution | |
| 31-03-321114 | In distribution | |
| 38-01-320015 | In distribution | |
| 31-02-281013 | In distribution | |
| 31-02-201012 | In distribution | |
| 31-02-301112 | In distribution | |
| 31-03-301114 | In distribution | |
| 31-03-301211 | In distribution |
Showing 250 of 300 catalogue numbers.
Same 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.
| 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.