Leksell Stereotactic System
Disposable Quick Fixation Screws, 13 Pairs
5manufacturers in China registered for this device type
199catalogue numbers in this listing
16510(k) clearances naming this product code
4recalls 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 | Elekta Instrument AB, Sweden |
|---|---|
| FDA product code | HAW |
| Device type | Neurological Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| 510(k) | K152558 |
| Record published | 2018-09-21 |
| Record revised | 2025-12-15 (version 6) |
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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Packaging | Pack of 25 |
| Sizes | Length 20 to 110 mm |
| Distribution end date | 2017-10-11 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1000598 | In distribution | ||
| 1000351 | In distribution | ||
| 1004084 | In distribution | ||
| 1003531 | In distribution | ||
| 1000582 | In distribution | ||
| 712060 | In distribution | ||
| 1001176 | In distribution | ||
| 1003681 | In distribution | ||
| 1020654 | In distribution | ||
| 917831 | In distribution | ||
| 1013578 | In distribution | ||
| 1003534 | In distribution | ||
| 918238 | In distribution | ||
| 709671 | In distribution | ||
| 1006745 | In distribution | ||
| 1003949 | 2 | In distribution | |
| 13012680 | Length 65.0 mm | In distribution | |
| 12004601 | In distribution | ||
| 1003676 | Length 25.0 mm | In distribution | |
| 1003687 | In distribution | ||
| 13012720 | In distribution | ||
| 13012660 | In distribution | ||
| 717489 | In distribution | ||
| 1006581 | In distribution | ||
| 1000563 | In distribution | ||
| 917120 | In distribution | ||
| 1000689 | In distribution | ||
| 707483 | Length 55.0 mm | In distribution | |
| 13012550 | Length 22.5 mm | In distribution | |
| 814933 | In distribution | ||
| 1003838 | In distribution | ||
| 1002248 | In distribution | ||
| A0202-01 | In distribution | ||
| 1014413 | In distribution | ||
| 14010560 | Length 90.0 mm | In distribution | |
| A0401-05 | In distribution | ||
| 1004081 | Length 22.5 mm | In distribution | |
| 1001184 | In distribution | ||
| 1003594 | In distribution | ||
| 13012700 | Length 75.0 mm | In distribution | |
| 707479 | Length 35.0 mm | In distribution | |
| 14010540 | Length 45.0 mm | In distribution | |
| 1014150 | In distribution | ||
| A0860-04 | In distribution | ||
| 1002031 | In distribution | ||
| 707478 | In distribution | ||
| 709667 | Length 27.5 mm | In distribution | |
| 1003683 | In distribution | ||
| A0440-07 | In distribution | ||
| 1003533 | In distribution | ||
| 13012570 | Length 27.5 mm | In distribution | |
| 1003948 | 2 | In distribution | |
| 13012640 | In distribution | ||
| 1006559 | In distribution | ||
| 14010550 | Length 65.0 mm | In distribution | |
| 1003670 | In distribution | ||
| 1000573 | In distribution | ||
| 302195 | Length 70.0 mm | In distribution | |
| 407010 | In distribution | ||
| 1003689 | In distribution | ||
| 707480 | Length 40.0 mm | In distribution | |
| 402189 | Length 30.0 mm | In distribution | |
| 1003684 | Length 65.0 mm | In distribution | |
| 1003685 | Length 70.0 mm | In distribution | |
| 907999 | In distribution | ||
| 914798 | In distribution | ||
| 13012730 | In distribution | ||
| 1002678 | In distribution | ||
| 1007283 | In distribution | ||
| 1021148 | In distribution | ||
| 1530036 | In distribution | ||
| 404889 | Length 22.5 mm | In distribution | |
| 1003965 | In distribution | ||
| 709672 | In distribution | ||
| 1002140 | In distribution | ||
| 1002136 | In distribution | ||
| 1000116 | In distribution | ||
| 912877 | 4 | In distribution | |
| A0440-02 | In distribution | ||
| 13012560 | In distribution | ||
| 1000705 | In distribution | ||
| 1003678 | Length 35.0 mm | In distribution | |
| 709669 | In distribution | ||
| 307031 | In distribution | ||
| 1000566 | In distribution | ||
| 1003682 | Length 55.0 mm | In distribution | |
| 302193 | Length 55.0 mm | In distribution | |
| 1004083 | In distribution | ||
| 13012610 | In distribution | ||
| A0401-14 | In distribution | ||
| 50152-04 | In distribution | ||
| 1003680 | In distribution | ||
| 60136-01 | In distribution | ||
| 1530039 | In distribution | ||
| 917119 | In distribution | ||
| 912965 | In distribution | ||
| 911337 | In distribution | ||
| 1000075 | In distribution | ||
| 60361-01 | In distribution | ||
| 1006748 | In distribution | ||
| 60725-01 | In distribution | ||
| 814932 | In distribution | ||
| 1000704 | In distribution | ||
| 716255 | In distribution | ||
| 709670 | In distribution | ||
| 13012630 | Length 42.5 mm | In distribution | |
| 60300-01 | In distribution | ||
| 811105 | In distribution | ||
| 1002115 | In distribution | ||
| 1000810 | In distribution | ||
| A1200-04 | In distribution | ||
| 917118 | In distribution | ||
| 1003530 | In distribution | ||
| 1001015 | In distribution | ||
| 1003593 | In distribution | ||
| 709674 | Length 80.0 mm | In distribution | |
| A0420-10 | In distribution | ||
| 13012690 | In distribution | ||
| A0401-15 | In distribution | ||
| 717485 | In distribution | ||
| 1530041 | In distribution | ||
| 1003677 | Length 30.0 mm | In distribution | |
| A0420-24 | In distribution | ||
| 13012710 | In distribution | ||
| 1000349 | In distribution | ||
| 1004085 | Length 42.5 mm | In distribution | |
| 404888 | In distribution | ||
| 402188 | In distribution | ||
| 402192 | Length 50.0 mm | In distribution | |
| 302197 | In distribution | ||
| 1003957 | 2 | In distribution | |
| 709668 | In distribution | ||
| 302196 | In distribution | ||
| 707481 | Length 45.0 mm | In distribution | |
| 402190 | In distribution | ||
| 13012650 | In distribution | ||
| A0420-26 | In distribution | ||
| 13012540 | Length 20.0 mm | In distribution | |
| 1000575 | In distribution | ||
| 917171 | In distribution | ||
| 404890 | In distribution | ||
| 1003951 | 2 | In distribution | |
| 1016899 | In distribution | ||
| 104522 | In distribution | ||
| 707484 | In distribution | ||
| A0227-04 | In distribution | ||
| 1003679 | In distribution | ||
| 1003686 | Length 75.0 mm | In distribution | |
| 302194 | In distribution | ||
| A0820-07 | In distribution | ||
| 1000560 | In distribution | ||
| 60082-05 | In distribution | ||
| 13012590 | In distribution | ||
| 402191 | In distribution | ||
| A0420-25 | In distribution | ||
| 1000559 | In distribution | ||
| 1006584 | In distribution | ||
| A0440-05 | In distribution | ||
| 1006743 | In distribution | ||
| 1003958 | 2 | In distribution | |
| 1014734 | In distribution | ||
| 712059 | In distribution | ||
| 1530040 | In distribution | ||
| 1004820 | In distribution | ||
| 12004590 | In distribution | ||
| 1006472 | In distribution | ||
| A0440-04 | In distribution | ||
| 1000579 | In distribution | ||
| 1003675 | Length 20.0 mm | In distribution | |
| 1000487 | In distribution | ||
| 1004082 | In distribution | ||
| 1023815 | In distribution | ||
| 714973 | In distribution | ||
| 13012670 | Length 60.0 mm | In distribution | |
| 1003688 | In distribution | ||
| 1530038 | In distribution | ||
| 709675 | In distribution | ||
| 1000700 | In distribution | ||
| 50695-01 | In distribution | ||
| 917830 | In distribution | ||
| 1003960 | 2 | In distribution | |
| 13012600 | In distribution | ||
| 716252 | In distribution | ||
| 707482 | In distribution | ||
| 13012620 | Length 40.0 mm | In distribution | |
| 1020954 | In distribution | ||
| 1028779 | In distribution | ||
| A0440-01 | In distribution | ||
| 709676 | In distribution | ||
| 1004312 | In distribution | ||
| 1000699 | In distribution | ||
| 13004630 | In distribution | ||
| 916282 | In distribution | ||
| 1006749 | In distribution | ||
| A0420-29 | In distribution | ||
| 1006747 | In distribution | ||
| 709673 | Length 75.0 mm | In distribution | |
| 1002044 | Withdrawn | ||
| A0420-30 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neurological Stereotaxic Instrument | Medtronic Navigation, Inc. | 844 |
| PMT Corporation – Stereotactic | PMT Corp. | 255 |
| 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 |
| microTargeting™ Insertion Tube | FHC, Inc. | 48 |
Showing 12 of 1,137. All products under Neurological Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190887 | 2019-08-01 |
| K171123 | 2017-09-15 |
| K152558 | 2016-03-02 |
| K080355 | 2009-05-01 |
| K080250 | 2008-05-13 |
| K051746 | 2005-07-25 |
| K040979 | 2004-07-23 |
| K033340 | 2004-02-12 |
| K031999 | 2003-07-25 |
| K031980 | 2003-07-25 |
| K013861 | 2001-12-06 |
| K992882 | 1999-09-24 |
| K991636 | 1999-07-20 |
| K973684 | 1998-03-31 |
| K972324 | 1998-03-02 |
| K961639 | 1996-07-26 |
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 |
|---|---|---|---|---|---|---|
| Elekta Instrument AB | 510(k) number | 2024-09-25 | Class I | Under Investigation by firm | Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on th | 111 kits (666 needles) |
| Elekta Instrument AB | 510(k) number | 2024-03-15 | Class I | Under Investigation by firm | Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy ne | 601 needles |
| Elekta Instrument AB | 510(k) number | 2023-03-01 | Class II | Labeling Change Control | The incorrect IFU was distributed with the devices. | 70 devices |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2020-06-10 | Class II | Device Design | The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly. | 51 devices | 2024-08-27 |
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.