Bun-Yo-Matic™ Lapidus Clamp System
Lapidus Nail Tissue Protector, Rotated 90
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 | Paragon 28, 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, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-11-08 |
| Record revised | 2025-04-22 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P30-100-5310 | In distribution |
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 |
| Pelvic Drill, 2.5mm | Zimmer, Inc. | 1 |
| Aries-L Lateral Lumbar Interbody System | Osseus Fusion Systems LLC | 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.