Nexframe Screws
1.6 x 10mm Cranial Bone Screws (3)
5manufacturers in China registered for this device type
2catalogue numbers in this listing
6510(k) clearances naming this product code
24recalls 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 | FHC, Inc., United States |
|---|---|
| FDA product code | HAW |
| Device type | Neurological Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K012366 |
| Record published | 2020-11-05 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature -34 to 57 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SR-10-00804 | 3 | In distribution | |
| SR-10-00873 | 3 | 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 |
|---|---|
| K121950 | 2012-07-26 |
| K092192 | 2010-02-12 |
| K092562 | 2009-09-18 |
| K011775 | 2001-08-30 |
| K011992 | 2001-08-14 |
| K003776 | 2001-02-23 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medtronic Image Guided Neurologics, Inc. | 510(k) number | 2007-10-04 | Not classified | Package design/selection | Sterilty (package integrity) Compromised: Some failures were for damage to the outer pouch, while another set of failures were for the seals on this pouch. The seal between the inner tray and lid has not been compromised and the contents | 385 | 2012-07-13 |
Recalls
1 of these is 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. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-10-04 | Class I | Process change control | A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigation revealed a schematic for a spacer tube which is too long relative to the size of other components was included in the build order for Lot 244 | 8 packs of 5ea (40 total) | |
| 2018-05-10 | Class II | Device Design | The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, | 2952 total | 2019-04-30 |
| 2018-05-10 | Class II | Device Design | The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, | 2952 total | 2019-04-30 |
| 2018-05-10 | Class II | Device Design | The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, | 2952 total | 2019-04-30 |
| 2018-05-10 | Class II | Device Design | The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, | 2952 total | 2019-04-30 |
| 2018-05-10 | Class II | Device Design | The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, | 2952 total | 2019-04-30 |
| 2018-05-10 | Class II | Device Design | The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, | 2952 total | 2019-04-30 |
| 2018-05-10 | Class II | Device Design | The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, | 2952 total | 2019-04-30 |
| 2018-05-10 | Class II | Device Design | The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, | 2952 total | 2019-04-30 |
| 2018-05-10 | Class II | Device Design | The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, | 2952 total | 2019-04-30 |
| 2018-05-10 | Class II | Device Design | The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, | 2952 total | 2019-04-30 |
| 2018-05-10 | Class II | Device Design | The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, | 2952 total | 2019-04-30 |
| 2018-05-10 | Class II | Device Design | The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, | 2952 total | 2019-04-30 |
| 2018-05-10 | Class II | Device Design | The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, | 2952 total | 2019-04-30 |
| 2018-05-10 | Class II | Device Design | The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, | 2952 total | 2019-04-30 |
| 2018-05-10 | Class II | Device Design | The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, | 2952 total | 2019-04-30 |
| 2010-03-30 | Not classified | Device Design | Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead. | 18 units | 2015-02-25 |
| 2010-03-30 | Not classified | Device Design | Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead. | 37 | 2015-02-25 |
| 2010-03-30 | Not classified | Device Design | Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead. | 7 | 2015-02-25 |
| 2010-03-30 | Not classified | Device Design | Fixation thumbscrew on the DBS depth stop adapter may be overtightened and damage the implantable lead. | 1 | 2015-02-25 |
| 2008-10-08 | Not classified | Process control | Measuring fixture is incorrectly graduated. | 5 units | 2012-05-02 |
| 2005-10-31 | Not classified | Other | Power Assist microTargeting System may advance beyond intended target | 70 units | 2006-06-07 |
| 2005-10-31 | Not classified | Other | Power Assist microTargeting System may advance beyond intended target | 230 units | 2006-06-07 |
| 2005-03-14 | Not classified | Other | Potential for non-sterile pin to contaminate sterile field | 169 units | 2008-07-08 |
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.