Leksell Vantage Stereotactic System
Leksell Vantage Head Frame Positioning Band
5manufacturers in China registered for this device type
42catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Sinovation (Beijing) Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 1 |
Record
| Listed by | Elekta Solutions AB, Sweden |
|---|---|
| FDA product code | HAW |
| Device type | Neurological Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K190887 |
| Record published | 2024-08-05 |
| Record revised | 2025-06-12 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Pack of 20 |
| Distribution end date | 2026-06-10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1040019 | FirmFix™ size | In distribution | |
| 1040051 | In distribution | ||
| 1040017 | FirmFix™ size | In distribution | |
| 1040134 | In distribution | ||
| 1040036 | In distribution | ||
| 1040124 | In distribution | ||
| 1040130 | In distribution | ||
| 1040125 | In distribution | ||
| 1040015 | FirmFix™ size | In distribution | |
| 1040128 | In distribution | ||
| 1040014 | In distribution | ||
| 1040114 | In distribution | ||
| 1040087 | In distribution | ||
| 1040066 | In distribution | ||
| 1040050 | In distribution | ||
| 1040045 | In distribution | ||
| 1040110 | In distribution | ||
| 1040123 | In distribution | ||
| 1040096 | In distribution | ||
| 1040062 | In distribution | ||
| 1060488 | In distribution | ||
| 1040136 | In distribution | ||
| 1040133 | In distribution | ||
| 1040079 | In distribution | ||
| 1040048 | In distribution | ||
| 1040100 | In distribution | ||
| 1040080 | In distribution | ||
| 1040093 | In distribution | ||
| 1040025 | In distribution | ||
| 1040090 | In distribution | ||
| 1040075 | In distribution | ||
| 1040026 | 200 | In distribution | |
| 1119115 | In distribution | ||
| 1040021 | FirmFix™ size | In distribution | |
| 1040023 | FirmFix™ size | In distribution | |
| 1040131 | In distribution | ||
| 1040041 | In distribution | ||
| 1040126 | In distribution | ||
| 1040132 | In distribution | ||
| 1040067 | In distribution | ||
| 1040036 | Withdrawn | ||
| 1040064 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neurological Stereotaxic Instrument | Medtronic Navigation, Inc. | 844 |
| PMT Corporation – Stereotactic | PMT Corp. | 255 |
| Leksell Stereotactic System | Elekta Instrument AB | 199 |
| Neurological Stereotaxic Instrument | Inomed Medizintechnik Gmbh | 146 |
| Neurological Stereotaxic Instrument | Stryker Leibinger Gmbh & Co. KG | 125 |
| Geniant Cranial | KOH Young Technology Inc. | 113 |
| CRW® | Integra Lifesciences Corporation | 107 |
| Leksell Stereotactic System | Elekta Solutions AB | 93 |
| microTargeting™ Insertion Tube with Stylet | FHC, Inc. | 60 |
| Leksell Stereotactic System Neurosurgical Instruments | Elekta Instrument AB | 58 |
| Leksell Vantage Stereotactic System | Elekta Instrument AB | 53 |
| Stealth Autoguide™ System | Medtronic Navigation, Inc. | 50 |
Showing 12 of 1,137. All products under Neurological Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261932 | 2026-08-05 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Elekta Inc. | 510(k) number | 2026-03-19 | Class II | Device Design | Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures. | 768 (364Left/364Right) | |
| Elekta Inc. | 510(k) number | 2025-09-30 | Class II | Process change control | Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound | 338 | |
| Elekta Inc. | 510(k) number | 2020-03-30 | Class II | Process design | A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking force to the Arc has been found during an internal check of a Leksell Vantage Stereotactic Arc System. | 25 units. | 2024-04-10 |
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.