NDI Passive Spheres
Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 1 sphere per…
Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 1 sphere per inner pouch with 4 inner pouches in an outer pouch. There are 5 pouch-in-pouches for a total of 20 spheres.
5manufacturers in China registered for this device type
11catalogue numbers in this listing
1510(k) clearance
2recalls 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 | Northern Digital, Inc., Canada |
|---|---|
| FDA product code | HAW |
| Device type | Neurological Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K033621 |
| Record published | 2016-09-24 |
| Record revised | 2018-07-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Tray in pouch of 12, tray in pouch of 2, pouch in pouch of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8801054 | In distribution | |
| 8801053 | In distribution | |
| 8801051 | In distribution | |
| 8800737 | In distribution | |
| 8800739 | In distribution | |
| 8801002 | In distribution | |
| 8800738 | In distribution | |
| 8800965 | In distribution | |
| 8800966 | In distribution | |
| 8800967 | In distribution | |
| 8801320 | 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 |
|---|---|
| K033621 | 2004-01-27 |
Recalls Naming This Product
23 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 |
|---|---|---|---|---|---|---|---|
| Medtronic Navigation, Inc. | 510(k) number | 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| Medtronic Navigation, Inc. | 510(k) number | 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| Medtronic Navigation, Inc. | 510(k) number | 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| Medtronic Navigation, Inc. | 510(k) number | 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| Medtronic Navigation, Inc. | 510(k) number | 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| Medtronic Navigation, Inc. | 510(k) number | 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| Medtronic Navigation, Inc. | 510(k) number | 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| Medtronic Navigation, Inc. | 510(k) number | 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| Medtronic Navigation, Inc. | 510(k) number | 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| Medtronic Navigation, Inc. | 510(k) number | 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| Medtronic Navigation, Inc. | 510(k) number | 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| Medtronic Navigation, Inc. | 510(k) number | 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| Medtronic Navigation, Inc. | 510(k) number | 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| Medtronic Navigation, Inc. | 510(k) number | 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| Medtronic Navigation, Inc. | 510(k) number | 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| Medtronic Navigation, Inc. | 510(k) number | 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| Medtronic Navigation, Inc. | 510(k) number | 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| Medtronic Navigation, Inc. | 510(k) number | 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| Medtronic Navigation, Inc. | 510(k) number | 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| Medtronic Navigation, Inc. | 510(k) number | 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| Medtronic Navigation, Inc. | 510(k) number | 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| Medtronic Navigation, Inc. | 510(k) number | 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
| Medtronic Navigation, Inc. | 510(k) number | 2014-04-24 | Class II | Nonconforming Material/Component | Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure ster | 26,674 total | 2014-12-29 |
Recalls
2 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 |
|---|---|---|---|---|---|
| 2015-06-10 | Class II | Process control | Inadequate curing of adhesive, may cause the two halves of the spheres to separate. | 524, 700 spheres (41773 = 440,820 spheres; 41774 = 77,760 sp | 2016-10-03 |
| 2015-05-20 | Class II | Process control | Inadequate curing of adhesive, which may cause the two halves of the spheres to separate. | 32,400 spheres | 2017-10-13 |
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.