TL-HEX Truelok Hexapod System
TL-HEX KIT Marker Pediatric
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Rooe Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 31 |
Record
| Listed by | Orthofix SRL, Italy |
|---|---|
| FDA product code | JAC |
| Device type | System, X-Ray, Film Marking, Radiographic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1640 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-06-01 |
| Record revised | 2025-10-24 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution | |
| 1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Suremark | Jessop Precision Products Inc. | 18 |
| N-Spot | Beekley Corporation | 16 |
| PortalMark | Jessop Precision Products Inc. | 14 |
| Xact | Solstice Corporation | 14 |
| TomoSPOT | Beekley Corporation | 10 |
| RT-Spot | Beekley Corporation | 8 |
| O-Spot | Beekley Corporation | 8 |
| MR-Spot | Beekley Corporation | 8 |
| CT-Spot | Beekley Corporation | 8 |
| S-Spot | Beekley Corporation | 8 |
| CT-Markers | Nucletron B.V. | 7 |
| Scaneez | Jessop Precision Products Inc. | 7 |
Showing 12 of 68. All products under System, X-Ray, Film Marking, Radiographic
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.