ClearPoint
SF M6 Bolt Driver
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
Record
| Listed by | ClearPoint Neuro Inc., United States |
|---|---|
| FDA product code | LRZ |
| Device type | Screwdriver, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-01-22 |
| Record revised | 2026-04-01 (version 6) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2025-11-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NGS-BD-M6 | In distribution | |
| NGS-HX-M6 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bioplate® | Bioplate, Inc. | 46 |
| Faico CMF System | Faico Medical, LLC | 40 |
| Orthomed | Ortho-MED, Inc. | 37 |
| Dental Instrument | Cowellmedi Co., Ltd. | 26 |
| A.l.p.s. mvX™ | Tyber Medical | 12 |
| Titanex | Vilex LLC | 9 |
| Torque Shank | I.T.S. Gmbh | 5 |
| Hexagon-Shank | I.T.S. Gmbh | 5 |
| Leos Cannulated Screw System | Tyber Medical | 5 |
| Screw Driver | I.T.S. Gmbh | 4 |
| Screwdriver Shank | I.T.S. Gmbh | 4 |
| Dynex | Vilex LLC | 4 |
Showing 12 of 32. All products under Screwdriver, Surgical
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.