Cougar
COUGAR LS LATERAL CAGE SYSTEM LORDOTIC CAGE 18 x 10 x 45mm, 15 DEGREES
14manufacturers in China registered for this device type
191catalogue numbers in this listing
1510(k) clearance
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 | Medos International Sàrl, Switzerland |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K082128 |
| Record published | 2015-09-24 |
| Record revised | 2026-05-29 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 189150716 | In distribution | |
| 189155814 | In distribution | |
| 189130106 | In distribution | |
| 189155416 | In distribution | |
| 187120320 | In distribution | |
| 189145610 | In distribution | |
| 189145708 | In distribution | |
| 189150311 | In distribution | |
| 189145810 | In distribution | |
| 189155808 | In distribution | |
| 189150910 | In distribution | |
| 189145214 | In distribution | |
| 189140508 | In distribution | |
| 189140110 | In distribution | |
| 189155708 | In distribution | |
| 189135108 | In distribution | |
| 189150812 | In distribution | |
| 189140108 | In distribution | |
| 189150514 | In distribution | |
| 189145916 | In distribution | |
| 189145207 | In distribution | |
| 189145712 | In distribution | |
| 189145411 | In distribution | |
| 189160816 | In distribution | |
| 189155210 | In distribution | |
| 189145807 | In distribution | |
| 189135110 | In distribution | |
| 189155214 | In distribution | |
| 189155810 | In distribution | |
| 189150612 | In distribution | |
| 189150411 | In distribution | |
| 189160311 | In distribution | |
| 189155112 | In distribution | |
| 189130110 | In distribution | |
| 189145507 | In distribution | |
| 189145413 | In distribution | |
| 189140212 | In distribution | |
| 187120214 | In distribution | |
| 189160414 | In distribution | |
| 189160914 | In distribution | |
| 187120220 | In distribution | |
| 189145816 | In distribution | |
| 189140516 | In distribution | |
| 189140112 | In distribution | |
| 189155212 | In distribution | |
| 189160406 | In distribution | |
| 189150410 | In distribution | |
| 189150108 | In distribution | |
| 189140414 | In distribution | |
| 189150511 | In distribution | |
| 189160412 | In distribution | |
| 189145714 | In distribution | |
| 189135408 | In distribution | |
| 189145710 | In distribution | |
| 189145814 | In distribution | |
| 189160812 | In distribution | |
| 189145512 | In distribution | |
| 189135510 | In distribution | |
| 189155408 | In distribution | |
| 189130510 | In distribution | |
| 189150807 | In distribution | |
| 189140507 | In distribution | |
| 189160410 | In distribution | |
| 189145514 | In distribution | |
| 189150508 | In distribution | |
| 189155412 | In distribution | |
| 189150208 | In distribution | |
| 189155406 | In distribution | |
| 189145408 | In distribution | |
| 189160814 | In distribution | |
| 189145412 | In distribution | |
| 189155807 | In distribution | |
| 189145208 | In distribution | |
| 189155208 | In distribution | |
| 189155710 | In distribution | |
| 189135112 | In distribution | |
| 189140210 | In distribution | |
| 189160912 | In distribution | |
| 189150112 | In distribution | |
| 189150512 | In distribution | |
| 189130508 | In distribution | |
| 189150808 | In distribution | |
| 189145716 | In distribution | |
| 189150616 | In distribution | |
| 189155311 | In distribution | |
| 189155714 | In distribution | |
| 189155108 | In distribution | |
| 187120318 | In distribution | |
| 189150212 | In distribution | |
| 189155410 | In distribution | |
| 189160716 | In distribution | |
| 189155106 | In distribution | |
| 189155712 | In distribution | |
| 189140416 | In distribution | |
| 189160708 | In distribution | |
| 189140812 | In distribution | |
| 189150414 | In distribution | |
| 189160512 | In distribution | |
| 187120216 | In distribution | |
| 189135508 | In distribution | |
| 189155816 | In distribution | |
| 189140408 | In distribution | |
| 189145108 | In distribution | |
| 189150916 | In distribution | |
| 189160514 | In distribution | |
| 189155508 | In distribution | |
| 189155614 | In distribution | |
| 189150708 | In distribution | |
| 189140410 | In distribution | |
| 189145416 | In distribution | |
| 187120114 | In distribution | |
| 189155411 | In distribution | |
| 189140708 | In distribution | |
| 189150210 | In distribution | |
| 189150416 | In distribution | |
| 189160712 | In distribution | |
| 189150712 | In distribution | |
| 189155418 | In distribution | |
| 189145414 | In distribution | |
| 189145614 | In distribution | |
| 189140810 | In distribution | |
| 189150710 | In distribution | |
| 189150516 | In distribution | |
| 189155812 | In distribution | |
| 189140714 | In distribution | |
| 189155716 | In distribution | |
| 189155413 | In distribution | |
| 189135410 | In distribution | |
| 189155409 | In distribution | |
| 189145808 | In distribution | |
| 189145812 | In distribution | |
| 189130408 | In distribution | |
| 189160910 | In distribution | |
| 189150418 | In distribution | |
| 189160714 | In distribution | |
| 189150814 | In distribution | |
| 189140710 | In distribution | |
| 189145311 | In distribution | |
| 189145212 | In distribution | |
| 189155110 | In distribution | |
| 189150214 | In distribution | |
| 189150706 | In distribution | |
| 189155510 | In distribution | |
| 189150507 | In distribution | |
| 189135210 | In distribution | |
| 189160710 | In distribution | |
| 189155511 | In distribution | |
| 189140412 | In distribution | |
| 189140814 | In distribution | |
| 189150408 | In distribution | |
| 189145110 | In distribution | |
| 189145910 | In distribution | |
| 189160510 | In distribution | |
| 189145410 | In distribution | |
| 189140816 | In distribution | |
| 189145114 | In distribution | |
| 189145112 | In distribution | |
| 189145510 | In distribution | |
| 189150413 | In distribution | |
| 189135212 | In distribution | |
| 189150510 | In distribution | |
| 189160416 | In distribution | |
| 189130108 | In distribution | |
| 189140716 | In distribution | |
| 189160516 | In distribution | |
| 189155516 | In distribution | |
| 189160408 | In distribution | |
| 189150816 | In distribution | |
| 189140510 | In distribution | |
| 189150110 | In distribution | |
| 189155414 | In distribution | |
| 189150409 | In distribution | |
| 189145106 | In distribution | |
| 189145210 | In distribution | |
| 189150714 | In distribution | |
| 189155514 | In distribution | |
| 189140514 | In distribution | |
| 189150412 | In distribution | |
| 189145516 | In distribution | |
| 189155512 | In distribution | |
| 189140311 | In distribution | |
| 189160508 | In distribution | |
| 189140512 | In distribution | |
| 189145508 | In distribution | |
| 189145616 | In distribution | |
| 189140712 | In distribution | |
| 189150810 | In distribution | |
| 189145409 | In distribution | |
| 187120116 | In distribution | |
| 189155114 | In distribution | |
| 189130410 | In distribution |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223688 | 2023-03-08 |
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.