Aries-TS Tslif Lumbar Interbody System
10x28x15, 0 Deg, Sterile, TSLIF Interbody, Aries-TS
14manufacturers in China registered for this device type
60catalogue 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 | Osseus Fusion Systems 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 | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K181347 |
| Record published | 2020-05-05 |
| Record revised | 2025-07-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1100-0123 | In distribution | |
| 1100-0328S | In distribution | |
| 1100-1121S | In distribution | |
| 1100-0129S | In distribution | |
| 1100-0527S | In distribution | |
| 1100-0323 | In distribution | |
| 1100-1523S | In distribution | |
| 1100-0122 | In distribution | |
| 1100-0528S | In distribution | |
| 1100-1126S | In distribution | |
| 1100-1522S | In distribution | |
| 1100-0125 | In distribution | |
| 1100-1526S | In distribution | |
| 1100-0522S | In distribution | |
| 1100-1321S | In distribution | |
| 1100-1125S | In distribution | |
| 1100-0120 | In distribution | |
| 1100-1127S | In distribution | |
| 1100-0126S | In distribution | |
| 1100-0121 | In distribution | |
| 1100-0322 | In distribution | |
| 1100-0524S | In distribution | |
| 1100-1320S | In distribution | |
| 1100-0325 | In distribution | |
| 1100-0329S | In distribution | |
| 1100-1127S | In distribution | |
| 1100-1328S | In distribution | |
| 1100-1324S | In distribution | |
| 1100-0524S | In distribution | |
| 1100-0523S | In distribution | |
| 1100-0326S | In distribution | |
| 1100-1322S | In distribution | |
| 1100-0526S | In distribution | |
| 1100-0324 | In distribution | |
| 1100-1527S | In distribution | |
| 1100-1329S | In distribution | |
| 1100-1123S | In distribution | |
| 1100-0127S | In distribution | |
| 1100-0529S | In distribution | |
| 1100-1529S | In distribution | |
| 1100-0520S | In distribution | |
| 1100-0320 | In distribution | |
| 1100-0521S | In distribution | |
| 1100-1120S | In distribution | |
| 1100-1323S | In distribution | |
| 1100-0124 | In distribution | |
| 1100-0525S | In distribution | |
| 1100-1327S | In distribution | |
| 1100-0327S | In distribution | |
| 1100-1129S | In distribution | |
| 1100-1528S | In distribution | |
| 1100-1128S | In distribution | |
| 1100-1325S | In distribution | |
| 1100-1524S | In distribution | |
| 1100-1326S | In distribution | |
| 1100-1521S | In distribution | |
| 1100-1525S | In distribution | |
| 1100-0128S | In distribution | |
| 1100-1520S | In distribution | |
| 1100-0321 | 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 |
|---|---|
| K181347 | 2018-08-15 |
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.