Medtronic Navigation
SFW KIT 9735738 Stealth S8 CRN DBS EU-SE
5manufacturers in China registered for this device type
43catalogue numbers in this listing
19510(k) clearances naming this product code
40recalls on this code
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 | Medtronic Navigation, Inc., United States |
|---|---|
| FDA product code | HAW |
| Device type | Neurological Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K203639 |
| Record published | 2021-04-10 |
| Record revised | 2023-09-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9735737 | In distribution | |
| 9735737 | In distribution | |
| 9735738 | In distribution | |
| 9735739 | In distribution | |
| 9735917 | In distribution | |
| 9735921 | In distribution | |
| 9735738 | In distribution | |
| 9735916 | In distribution | |
| 9735739 | In distribution | |
| 9735739 | In distribution | |
| 9735916 | In distribution | |
| 9735737 | In distribution | |
| 9736025 | In distribution | |
| 9735921 | In distribution | |
| 9735916 | In distribution | |
| 9735737 | In distribution | |
| 9735739 | In distribution | |
| 9735916 | In distribution | |
| 9735737 | In distribution | |
| 9735738 | In distribution | |
| 9735739 | In distribution | |
| 9735921 | In distribution | |
| 9736025 | In distribution | |
| 9735738 | In distribution | |
| 9735738 | In distribution | |
| 9735921 | In distribution | |
| 9735739 | In distribution | |
| 9735921 | In distribution | |
| 9735918 | In distribution | |
| 9735916 | In distribution | |
| 9735737 | In distribution | |
| 9736025 | In distribution | |
| 9735917 | In distribution | |
| 9736025 | In distribution | |
| 9735918 | In distribution | |
| 9735739 | In distribution | |
| 9735738 | In distribution | |
| 9735916 | In distribution | |
| 9736025 | In distribution | |
| 9735916 | In distribution | |
| 9736025 | In distribution | |
| 9736025 | In distribution | |
| 9735737 | In distribution |
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 |
|---|---|
| K253379 | 2026-03-26 |
| K231976 | 2023-10-19 |
| K221087 | 2022-06-10 |
| K212397 | 2021-12-22 |
| K203639 | 2021-01-13 |
| K201175 | 2020-06-03 |
| K191597 | 2019-11-01 |
| K190672 | 2019-07-31 |
| K162655 | 2017-04-21 |
| K162309 | 2017-03-31 |
| K162604 | 2016-12-30 |
| K153660 | 2016-09-14 |
| K150216 | 2015-06-11 |
| K141833 | 2015-03-25 |
| K133444 | 2014-07-25 |
| K130608 | 2013-08-07 |
| K061248 | 2006-08-31 |
| K052623 | 2006-03-02 |
| K050651 | 2005-07-27 |
Recalls
7 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. 1 is recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-03-26 | Class I | Software design | Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the “distance to target” or “tip stop point” display during navigation. | 3286 applications. | |
| 2023-09-27 | Class I | Software design | Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location. | 5,240 affected systems | |
| 2023-04-11 | Class I | Software design | In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor resection/shunt placement/deep brain stimulation, where distance | 556 | |
| 2023-04-11 | Class I | Software design | During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no longer synchronize with other navigational information showing inaccurate values | 746 | |
| 2022-12-15 | Class II | Process control | Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints analysis indicates that users are unable to successfully verify their navigation instruments during image-guided surgery. | 1,867 devies | |
| 2021-11-11 | Class I | Software design | Cranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the navigational information on the screen and may display an incorrect position of the biopsy needle, which may res | 2587 | |
| 2021-11-09 | Class II | Process control | A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/weld failure, where the tracker connects to the instrument tube. If a weld separation occurs and a navigation inaccuracy is experienced, it may | 98 | |
| 2020-06-05 | Class II | Nonconforming Material/Component | There is a potential for specific camera units to be affected by a characterization issue during manufacturing that results in inaccurate navigation while utilizing both the active and passive trackers simultaneously. While no injuries or i | 2 | 2024-05-28 |
| 2019-10-30 | Class II | Process control | The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tighten to the biopsy needle. This could r | 10,448 disposable biopsy needles | |
| 2019-10-30 | Class II | Process control | The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tighten to the biopsy needle. This could r | 12 disposable biopsy needles | |
| 2019-10-30 | Class II | Process control | The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tighten to the biopsy needle. This could r | 1 disposable Biopsy Needle | |
| 2019-08-09 | Class I | Software design | Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of the firm’s Steriotactic System and auto-registration feature with a specific imaging syste | 61 customers purchased the specified combination of equipmen | 2024-04-02 |
| 2018-09-26 | Class I | Device Design | An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software, which resulted in the biopsy of healthy tissue. | 5487 impacted systems | 2024-09-05 |
| 2017-05-10 | Class II | Software in the Use Environment | Software issue related to the StealthStation S7 system and the Synergy Spine application Version 2.1 configured with Spine Tool Install CD version 25. Issue may result in user being unable to navigate the Navigated Elevate Inserter with th | 108 | 2021-01-08 |
| 2016-12-12 | Class II | Process change control | Medtronic Navigation, Inc. announces a voluntary field action for the AxIEM Touch N Go Pointer Probe because the patient registration accuracy may compromise navigation accuracy when using the StealthStation System with Touch N Go Pointer P | 111 devices | 2017-05-19 |
| 2016-07-18 | Class II | Software design | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners. | 27 in total | 2016-12-01 |
| 2016-07-18 | Class II | Software design | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners. | 27 in total | 2016-12-01 |
| 2016-07-18 | Class II | Software design | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners. | 27 in total | 2016-12-01 |
| 2016-07-18 | Class II | Software design | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners. | 27 in total | 2016-12-01 |
| 2016-07-18 | Class II | Software design | Medtronic Navigation, Inc. announces a voluntary field action for the Medtronic Navigation StealthStation Software applications affected by Neurologica BodyTom/CereTom floor-based scanners. | 27 in total | 2016-12-01 |
| 2016-02-22 | Class II | No Marketing Application | Medtronic Navigation is recalling the Biotex Adapter Kit because it was commercially distributed by BioTex without a cleared premarket [510(k)] from FDA. | 4 | 2016-06-15 |
| 2015-09-14 | Class II | Labeling design | Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery. | 2346 | 2015-12-03 |
| 2015-07-17 | Class II | Process change control | The adhesive between the sphere assembly and the biopsy needle shaft may be compromised, causing the sphere assembly to move on the needle shaft. This may result in inaccurate navigation and improper placement of the needles biopsy window | 1415 total | 2016-04-07 |
| 2015-07-17 | Class II | Process change control | The adhesive between the sphere assembly and the biopsy needle shaft may be compromised, causing the sphere assembly to move on the needle shaft. This may result in inaccurate navigation and improper placement of the needles biopsy window | 1415 total | 2016-04-07 |
| 2015-05-26 | Class II | Error in labeling | Medtronic Navigation is initiating a field correction due to the potential for injury which could occur as a result of cleaning the Medtronic Navigated Cannulated Taps. | 15,798 | 2015-10-23 |
| 2015-05-05 | Class II | Mixed-up of materials/components | Passive Planar Blunt Probe (Lot# 150223) was manufactured with a sharp tip rather than a blunt tip. | 18 | 2015-07-02 |
| 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
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.