Neurological Stereotaxic Instrument
43 catalogue numbers from 20-8000-020-15, listed by Orthosoft, Inc., Canada, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
43catalogue numbers in this listing
12510(k) clearances naming this product 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 | Orthosoft, Inc., Canada |
|---|---|
| FDA product code | HAW |
| Device type | Neurological Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| 510(k) | K060336 |
| Record published | 2016-09-12 |
| Record revised | 2025-12-01 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Outer diameter 3.2 to 6 mm; length 3.5 to 150 mm |
| Distribution end date | 2020-09-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 20-8000-020-15 | SZ6 Shape Configuration/Type | In distribution | |
| 20-8000-020-26 | In distribution | ||
| 20-8000-020-27 | In distribution | ||
| 302.4002 | In distribution | ||
| 20-8000-000-02 | Outer Diameter 3.2 mm | In distribution | |
| 20-8000-070-21 | In distribution | ||
| 20-8011-070-02 | In distribution | ||
| 20-8000-070-65 | In distribution | ||
| 20-8011-070-03 | In distribution | ||
| 20-8000-000-01 | Length 150 mm | In distribution | |
| 20-8000-010-21 | Withdrawn | ||
| 20-8000-010-45 | Outer Diameter 6 mm | Withdrawn | |
| 20-8000-020-03 | Withdrawn | ||
| 20-8000-020-25 | Withdrawn | ||
| 20-8000-020-05 | Withdrawn | ||
| 20-8000-010-12 | Withdrawn | ||
| 20-8000-010-28 | Withdrawn | ||
| 20-8000-070-46 | Withdrawn | ||
| 20-8000-010-52 | Withdrawn | ||
| 20-8000-010-27 | Withdrawn | ||
| 20-8000-000-04 | Outer Diameter 3.2 mm | 12 | Withdrawn |
| 20-8000-010-30 | Withdrawn | ||
| 20-8000-010-11 | Withdrawn | ||
| 20-8000-000-03 | Outer Diameter 3.2 mm | 12 | Withdrawn |
| 20-8000-010-47 | Withdrawn | ||
| 20-8000-020-11 | Withdrawn | ||
| 20-8000-010-01 | Withdrawn | ||
| 20-8000-020-16 | Withdrawn | ||
| 20-8000-020-12 | Withdrawn | ||
| 20-8000-020-13 | SZ3 Shape Configuration/Type | Withdrawn | |
| 20-8000-020-04 | Withdrawn | ||
| 20-8000-010-49 | Outer Diameter 6 mm | Withdrawn | |
| 20-8000-010-23 | Withdrawn | ||
| 20-8000-020-20 | Withdrawn | ||
| 20-8000-020-21 | 8×1.25 pitch diameter | Withdrawn | |
| 20-8000-070-11 | Withdrawn | ||
| 20-8000-020-24 | Withdrawn | ||
| 20-8000-010-54 | Length 3.5 mm | Withdrawn | |
| 20-8000-010-31 | Withdrawn | ||
| 20-8000-010-50 | Withdrawn | ||
| 20-8000-020-14 | SZ3 Shape Configuration/Type | Withdrawn | |
| 20-8000-010-48 | Withdrawn | ||
| 20-8000-020-10 | 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 |
|---|---|
| K071929 | 2007-09-19 |
| K071714 | 2007-07-20 |
| K060336 | 2006-04-28 |
| K043536 | 2005-01-14 |
| K041369 | 2004-06-22 |
| K032917 | 2003-10-21 |
| K030827 | 2003-05-23 |
| K031156 | 2003-05-09 |
| K022364 | 2003-02-04 |
| K021760 | 2002-08-27 |
| K002053 | 2000-08-03 |
| K981315 | 1998-07-09 |
Recalls Naming This Product
10 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 |
|---|---|---|---|---|---|---|---|
| Zimmer CAS | 510(k) number | 2022-01-07 | Class II | Under Investigation by firm | The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk is infection leading to surgical intervention. | 14 units US; 132 units OUS | |
| Zimmer CAS | 510(k) number | 2017-02-20 | Class II | Other | There has been an increase in the number of complaints regarding bent or broken Drive Pins of the Validation Tool manufactured with drawing Revision M to P | 84 | 2017-09-18 |
| Zimmer CAS | 510(k) number | 2015-04-19 | Class II | Device Design | Zimmer CAS has determined that the potential exists for the spikes on the iASSIST Tibial Alignment Guide to bend or break during insertion or extraction from the tibia during use. | 78 devices | 2016-05-13 |
| Zimmer CAS | 510(k) number | 2011-10-06 | Class II | Software design | Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System – OS Knee Universal software ORTHOsoft-UniTkr-2.3.2.6, due to a calibration sequence crash. | 105 | 2017-05-08 |
| Zimmer, Inc. | 510(k) number | 2009-11-02 | Not classified | Device Design | The power cord female receptacle is not recessed sufficiently and may present a shock hazard. | 71 | 2010-10-15 |
| Zimmer CAS | 510(k) number | 2008-10-28 | Class II | Software design | Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal software versions 2.2.0.82, 2.2.1.3, 2.1.6.0.2, D.54 and A.42 due to software issues resulting in erros and discrepancies. | 153 | 2017-05-15 |
| Zimmer, Inc. | 510(k) number | 2008-08-19 | Not classified | Software design | Incorrect parameters: If the user switches from one surgeon profile to another surgeon profile after completing anatomical landmark acquisition tasks, the application will continue to use the initial surgeon profile parameter values in the | 75 (34 U.S. and 41 international) | 2010-04-28 |
| Zimmer CAS | 510(k) number | 2008-06-20 | Class III | Software design | ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System – OS Knee Universal, due to software anomalies which were corrected with a new revision in version 2.2.1.3. | 152 | 2017-05-15 |
| Zimmer, Inc. | 510(k) number | 2007-08-06 | Not classified | Device Design | Inadequate weld on tracker, knob oversized and poor thread design on attachment screw results in seizing. The instrument may break during use, resulting in surgical delay and an increased risk of infection. | 39 | 2009-03-11 |
| Zimmer, Inc. | 510(k) number | 2006-04-27 | Not classified | Device Design | The three-point array may break during use, resulting in surgical delay and an increased risk of infection. | 239 | 2009-03-11 |
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.