PSS System
Rod Fork Rev A
1manufacturer
1catalogue number
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Precision Spine, Inc., United States |
|---|---|
| FDA product code | HXE |
| Device type | Fork |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-03-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SL-9002 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cross-Fuse® II PEEK IBF System | Pioneer Surgical Technology, Inc. | 5 |
| Malibu | Seaspine Orthopedics Corporation | 3 |
| Anax™ 5.5 CT Spinal System | CG MedTech Co., Ltd. | 3 |
| Faico CMF System | Faico Medical, LLC | 2 |
| Fork | KLS-Martin L.P. | 2 |
| Optima™ ZS Spinal System | CG MedTech Co., Ltd. | 2 |
| Activ C | Aesculap AG | 2 |
| Otelo Instrumentation | Spineart SA | 1 |
| Acura Stabilization System – Rod Lever/ Reduction Fork | Indius Medical Technologies PVT. Ltd. | 1 |
| Optima™ Spinal System | CG MedTech Co., Ltd. | 1 |
| Aesculap | Aesculap AG | 1 |
| Novocart | Aesculap AG | 1 |
Showing 12 of 18. All products under Fork
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.