Neurological Stereotaxic Instrument
Needle Sleeve
5manufacturers in China registered for this device type
1catalogue number
8510(k) clearances naming this product code
38recalls 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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | HAW |
| Device type | Neurological Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2023-03-17 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Storage environment humidity 10 to 90 % RH; Handling environment humidity 30 to 75 % RH; Handling environment temperature 10 to 35 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature -20 to 50 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6000-805-021 | 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 |
|---|---|
| K212194 | 2023-02-16 |
| K162929 | 2017-02-22 |
| K080450 | 2008-07-17 |
| K072271 | 2007-12-18 |
| K010204 | 2001-08-31 |
| K002732 | 2000-10-02 |
| K993239 | 2000-01-18 |
| K991706 | 1999-12-07 |
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-10-16 | Class II | Software Manufacturing/Software Deployment | Stryker Instruments and Stryker Leibinger GmbH & Co. KG are voluntarily recalling certain serial numbers Thoracic Pedicle Feelers that are used in conjunction with the Stryker Navigation System because the settings on the machine were highe | 28 | 2019-04-03 |
| 2015-05-04 | Class II | Process control | Stryker initiated a device recall of the Navigation System II-Cart, Camera Articulated Arm because there is a potential that the weld seam between the main stud and the two flaps on the Articulated Arm was not welded in the correct location | 72 | 2016-05-16 |
| 2014-05-13 | Class II | Process change control | The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may have been assembled without electrical insulation of the soldering joints | 20 | 2014-09-15 |
| 2014-05-13 | Class II | Process change control | The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may have been assembled without electrical insulation of the soldering joints | 20 | 2014-09-15 |
| 2010-11-10 | Not classified | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate correlatio | 1,155 total | 2011-06-01 |
| 2010-11-10 | Not classified | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate correlatio | 1,155 total | 2011-06-01 |
| 2010-11-10 | Not classified | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate correlatio | 1,155 total | 2011-06-01 |
| 2010-11-10 | Not classified | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate correlatio | 1,155 total | 2011-06-01 |
| 2010-11-10 | Not classified | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate correlatio | 1,155 total | 2011-06-01 |
| 2010-11-10 | Not classified | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate correlatio | 1,155 total | 2011-06-01 |
| 2010-11-10 | Not classified | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate correlatio | 1,155 total | 2011-06-01 |
| 2010-11-10 | Not classified | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate correlatio | 1,155 total | 2011-06-01 |
| 2010-11-10 | Not classified | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate correlatio | 1,155 total | 2011-06-01 |
| 2010-11-10 | Not classified | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate correlatio | 1,155 total | 2011-06-01 |
| 2010-11-10 | Not classified | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate correlatio | 1,155 total | 2011-06-01 |
| 2010-11-10 | Not classified | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate correlatio | 1,155 total | 2011-06-01 |
| 2010-11-10 | Not classified | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate correlatio | 1,155 total | 2011-06-01 |
| 2010-11-10 | Not classified | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate correlatio | 1,155 total | 2011-06-01 |
| 2010-11-10 | Not classified | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate correlatio | 1,155 total | 2011-06-01 |
| 2010-11-10 | Not classified | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate correlatio | 1,155 total | 2011-06-01 |
| 2010-11-10 | Not classified | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate correlatio | 1,155 total | 2011-06-01 |
| 2010-11-10 | Not classified | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate correlatio | 1,155 total | 2011-06-01 |
| 2010-11-10 | Not classified | Software design | When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate correlatio | 1,155 total | 2011-06-01 |
| 2009-10-26 | Not classified | Software design | Multiple software-related malfunctions may occur. The device may suddenly stop working, the screen may freeze, the screen may only be updated very slowly, the unit may not respond to user input, or the unit may only respond to user very sl | 2 replacement systems | 2009-12-31 |
| 2009-10-26 | Not classified | Software design | Multiple software-related malfunctions may occur. The device may suddenly stop working, the screen may freeze, the screen may only be updated very slowly, the unit may not respond to user input, or the unit may only respond to user very sl | 21 | 2009-12-31 |
| 2008-06-05 | Not classified | Labeling False and Misleading | Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures. | 28,861 boxes of all products. | 2009-12-01 |
| 2008-06-05 | Not classified | Labeling False and Misleading | Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures. | 28,861 boxes of all products. | 2009-12-01 |
| 2008-06-05 | Not classified | Labeling False and Misleading | Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures. | 28,861 boxes of all products. | 2009-12-01 |
| 2008-06-05 | Not classified | Labeling False and Misleading | Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures. | 28,861 boxes of all products. | 2009-12-01 |
| 2008-06-05 | Not classified | Labeling False and Misleading | Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures. | 28,861 boxes of all products. | 2009-12-01 |
| 2008-06-05 | Not classified | Labeling False and Misleading | Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures. | 28,861 boxes of all products. | 2009-12-01 |
| 2008-06-05 | Not classified | Labeling False and Misleading | Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures. | 28,861 boxes of all products. | 2009-12-01 |
| 2006-09-08 | Not classified | Other | A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire. | 218 units for Recalls Z-0005/0008-2007 | 2007-12-04 |
| 2006-09-08 | Not classified | Other | A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire. | 218 units for Recalls Z-0005/0008-2007 | 2007-12-04 |
| 2006-09-08 | Not classified | Other | A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire. | 218 units for Recalls Z-0005/0008-2007 | 2007-12-04 |
| 2006-09-08 | Not classified | Other | A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire. | 218 units for Recalls Z-0005/0008-2007 | 2007-12-04 |
| 2004-07-14 | Not classified | Other | The tracker is not locking adequately to the anchoring pin, resulting in unacceptable movement, which will affected the patient tracker system. | 2004-10-18 | |
| 2004-07-14 | Not classified | Other | The tracker is not locking adequately to the anchoring pin, resulting in unacceptable movement, which will affected the patient tracker system. | 2004-10-18 |
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.