Aries-L Lateral Lumbar Interbody System
20x60x12 8 degree
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (2), Guangxi (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Greeloy Industry Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 9 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| A & I Industries Ltd | Foshan | Guangdong | Manufacturer | 35 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
Record
| Listed by | Osseus Fusion Systems LLC, United States |
|---|---|
| FDA product code | FZK |
| Device type | Chair, Surgical, Non-Electrical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4950 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K181347 |
| Record published | 2020-05-12 |
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 |
| Distribution end date | 2020-05-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1450-1242 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hausted | GF Health Products, Inc | 3 |
| Pelvic Drill Sleeve | Zimmer, Inc. | 1 |
| Deknatel | Teleflex Medical LLC | 1 |
| Pelvic Screw Cannula | Zimmer, Inc. | 1 |
| Bun-Yo-Matic™ Lapidus Clamp System | Paragon 28 | 1 |
| Pelvic Drill, 2.5mm | Zimmer, Inc. | 1 |
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.