Neurological Stereotaxic Instrument
Suction Tube, 2.7MM Left Posterior-Fossa
5manufacturers in China registered for this device type
125catalogue numbers in this listing
2510(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 | Stryker Leibinger Gmbh & Co. KG, Germany |
|---|---|
| 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, Exporter |
| Record published | 2016-08-24 |
| Record revised | 2025-02-19 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: 3 V; Storage environment humidity 10 to 75 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment temperature 10 to 30 °C; Storage environment temperature -20 to 40 °C; Handling environment humidity 25 to 85 % RH |
| Packaging | Case of 5, pack of 5 |
| Sizes | Length 2 to 152 mm |
| Distribution end date | 2022-10-12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 6001-088-327 | Diameter: 2.7 Millimeter | In distribution | |
| 8000-040-017 | In distribution | ||
| 6002-005-000 | In distribution | ||
| 6003-028-000 | In distribution | ||
| 6000-055-000 | In distribution | ||
| 7700-055-000 | In distribution | ||
| 6007-551-000 | In distribution | ||
| 6003-175-000 | In distribution | ||
| 6007-103-110 | Length 110.0 mm | 2 | In distribution |
| 6004-013-020 | Diameter: 9.0 Inch | In distribution | |
| 6002-014-000 | Length 124.0 mm | In distribution | |
| 6001-088-427 | Diameter: 2.7 Millimeter | In distribution | |
| 6004-011-020 | Diameter: 9.0 Inch | In distribution | |
| 6007-004-100 | Length 100.0 mm | 2 | In distribution |
| 6000-999-002 | Diameter: 2.0 Millimeter | In distribution | |
| 6000-801-000 | In distribution | ||
| 6002-017-018 | Length 18.0 mm | In distribution | |
| 6000-999-003 | Diameter: 7.0 Millimeter | In distribution | |
| 6002-017-012 | Diameter: 3.0 Millimeter | In distribution | |
| 6000-060-000 | In distribution | ||
| 6004-509-000 | Diameter: 9.0 Inch | In distribution | |
| 8000-060-014 | In distribution | ||
| 6001-231-000 | In distribution | ||
| 6007-300-000 | In distribution | ||
| 6001-088-240 | Diameter: 4.0 Millimeter | In distribution | |
| 6001-386-000 | 5 | In distribution | |
| 6003-200-030 | In distribution | ||
| 6002-020-000 | Length 122.0 mm | In distribution | |
| 81-03902 | In distribution | ||
| 81-03405 | Diameter: 1.5 Millimeter | In distribution | |
| 6004-018-020 | Diameter: 11.0 Inch | In distribution | |
| 6001-022-000 | In distribution | ||
| 6003-029-000 | Thickness: 0.9 Millimeter | In distribution | |
| 6000-999-004 | Diameter: 13.0 Millimeter | In distribution | |
| 7700-054-000 | In distribution | ||
| 6000-007-000 | In distribution | ||
| 6000-804-060 | In distribution | ||
| 6007-008-000 | In distribution | ||
| 6001-380-000 | In distribution | ||
| 6002-150-025 | Diameter: 2.6 Millimeter | In distribution | |
| 6003-051-000 | Thickness: 1.1 Millimeter | In distribution | |
| 8000-060-004 | In distribution | ||
| 6001-088-127 | Diameter: 2.7 Millimeter | In distribution | |
| 7700-075-000 | In distribution | ||
| 6002-016-000 | Length 152.0 mm | In distribution | |
| 6002-100-025 | Diameter: 2.6 Millimeter | In distribution | |
| 8000-060-013 | In distribution | ||
| 8000-060-016 | In distribution | ||
| 81-03402 | Length 8.0 mm | 5 | In distribution |
| 6004-400-020 | In distribution | ||
| 81-80037 | In distribution | ||
| 6004-014-020 | Diameter: 9.0 Inch | In distribution | |
| 6004-400-000 | Diameter: 9.0 Inch | In distribution | |
| 6004-650-300 | In distribution | ||
| 6003-052-000 | Thickness: 1.2 Millimeter | In distribution | |
| 8000-060-018 | In distribution | ||
| 7700-064-000 | In distribution | ||
| 6001-088-027 | Diameter: 2.7 Millimeter | In distribution | |
| 6000-999-005 | Diameter: 27.0 Millimeter | In distribution | |
| 6004-012-020 | Diameter: 9.0 Inch | In distribution | |
| 6001-031-000 | In distribution | ||
| 81-03404 | Length 70.0 mm | In distribution | |
| 6007-003-100 | Diameter: 3.0 Millimeter | 2 | In distribution |
| 6001-131-000 | In distribution | ||
| 6003-300-021 | In distribution | ||
| 6001-088-227 | Diameter: 2.7 Millimeter | In distribution | |
| 6000-806-000 | In distribution | ||
| 7700-074-000 | In distribution | ||
| 8000-040-002 | In distribution | ||
| 8000-060-015 | In distribution | ||
| 6003-054-000 | Thickness: 1.4 Millimeter | In distribution | |
| 6001-088-140 | Diameter: 4.0 Millimeter | In distribution | |
| 6007-104-150 | Diameter: 4.0 Millimeter | 2 | In distribution |
| 6002-021-000 | Length 147.0 mm | In distribution | |
| 6001-020-000 | In distribution | ||
| 6000-010-000 | In distribution | ||
| 6000-074-000 | In distribution | ||
| 6001-232-000 | In distribution | ||
| 6002-300-000 | In distribution | ||
| 6004-016-020 | Diameter: 12.0 Inch | In distribution | |
| 8000-040-018 | In distribution | ||
| 6003-200-020 | In distribution | ||
| 6000-008-000 | In distribution | ||
| 6004-650-000 | In distribution | ||
| 6000-075-000 | In distribution | ||
| 6000-012-000 | In distribution | ||
| 6000-011-000 | In distribution | ||
| 6007-003-150 | Diameter: 3.0 Millimeter | 2 | In distribution |
| 6002-150-032 | Diameter: 3.3 Millimeter | In distribution | |
| 8000-050-007 | In distribution | ||
| 6003-250-000 | In distribution | ||
| 8000-060-017 | In distribution | ||
| 6001-021-000 | In distribution | ||
| 6000-804-030 | In distribution | ||
| 6002-700-000 | In distribution | ||
| 6003-050-000 | Thickness: 1.0 Millimeter | In distribution | |
| 6000-802-000 | In distribution | ||
| 8000-100-001 | 100 | In distribution | |
| 6001-032-000 | In distribution | ||
| 6003-055-000 | Thickness: 1.5 Millimeter | In distribution | |
| 6003-070-000 | In distribution | ||
| 6007-015-000 | In distribution | ||
| 6002-350-000 | In distribution | ||
| 6000-022-000 | Diameter: 24.0 Millimeter | In distribution | |
| 6004-512-000 | Diameter: 12.0 Inch | In distribution | |
| 6001-132-000 | In distribution | ||
| 8900-200-200 | In distribution | ||
| 81-80036 | In distribution | ||
| 6003-200-010 | In distribution | ||
| 6004-017-020 | Diameter: 12.0 Inch | In distribution | |
| 6001-088-040 | Diameter: 4.0 Millimeter | In distribution | |
| 81-03403 | Length 4.5 mm | 5 | In distribution |
| 6003-027-000 | In distribution | ||
| 6002-200-000 | In distribution | ||
| 8000-060-019 | In distribution | ||
| 6007-310-000 | In distribution | ||
| 8000-050-003 | In distribution | ||
| 7700-065-000 | In distribution | ||
| 8000-060-012 | In distribution | ||
| 6000-803-000 | In distribution | ||
| 6002-100-032 | Diameter: 3.3 Millimeter | In distribution | |
| 6001-200-012 | Withdrawn | ||
| 6001-200-052 | Length 5.2 mm | Withdrawn | |
| 6001-200-042 | Length 4.2 mm | Withdrawn | |
| 6001-200-010 | Length 2.0 mm | 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 |
| 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 |
| microTargeting™ Insertion Tube | FHC, Inc. | 48 |
Showing 12 of 1,137. All products under Neurological Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K022579 | 2003-06-02 |
| K012380 | 2001-12-03 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Stryker GmbH | UDI-DI | 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 |
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.