Neurological Stereotaxic Instrument

Which Manufacturers in China Make This?

2 of the 5 manufacturers in China registered for this device type are contract manufacturers, able to build to a buyer’s own specification. They are concentrated in Jiangsu, Beijing and Shandong, and 1 other province.

Medtronic (Changzhou) Medical Devices Technology Co., Ltd. Jiangsu
Paragon Medical Device (Changzhou) Co., Ltd. Jiangsu, contract manufacturer
Shandong Weigao Orthopaedic Device Co., Ltd. Shandong, contract manufacturer
Sinovation (Beijing) Medical Technology Co., Ltd. Beijing
Zimmer (Shanghai) Medical International Trading Co., Ltd. Shanghai

How Is HAW Classified?

Neurological Stereotaxic Instrument is FDA product code HAW, Class 2, 21 CFR 882.4560.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 1 clearance under this code; the FDA took 524 days from receipt to decision.

What Do the Recalls Say?

The FDA has recorded 197 recalls under this product code since 2003. None was by a company in China. 15 are Class I, the most serious grade.

The root causes the FDA records most often are Software design (50), Device Design (38) and Nonconforming Material/Component (29). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Neurological Stereotaxic Instrument

Starlink Suction Tube Frazier-Tip 45° Angled 10 FR

Catalogue number 55790-70, listed by Brainlab SE, Germany, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

SA Clamp Bridge

Catalogue number MAS0500-02, listed by Mazor Robotics Ltd., Israel, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

SIES-Long Drill 4×80,5 Pack

Catalogue number KIT0714-01, listed by Mazor Robotics Ltd., Israel, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Spine Reference X-Clamp Extension, 40 Mm

Catalogue number 55754, listed by Brainlab SE, Germany, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Microtargeting™ Lumen Cleaning Tool

Lumen cleaning tool for microTargeting(TM) Drive Matrix Bushings

Neurological Stereotaxic Instrument

Onpoint Snap Spherz 25PK

Catalogue number DS0212501, listed by IZI Medical Products LLC, United States, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Cranial Reference Frame B

cranial reference frame B for Navient

Neurological Stereotaxic Instrument

Alignment Reduction Tube Cranial 8.0 Mm / 10.0 Mm

Catalogue number 56416, listed by Brainlab SE, Germany, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Fluoro 3D/2D Kit (For 3d C-Arms)

Catalogue number 55720, listed by Brainlab SE, Germany, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Modus Nav Operator Cart

Catalogue number SYN-0982, listed by Synaptive Medical Inc, Canada, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Guide 1.8 Biopsy UI

Catalogue number 55980-01, listed by Brainlab SE, Germany, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Pointer, Blunt Tip

Catalogue number 41780-5G, listed by Brainlab SE, Germany, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Neuro|mate® – Frameless Head-Holder Ring

A part of the Frameless Head-holder kit, the patient's head is immobilized in the head-holder ring before doing imaging.

Neurological Stereotaxic Instrument

Disposable Self-Tapping Screw

Catalogue number 52128, listed by Brainlab SE, Germany, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Interface Plate Fd 20×20

Catalogue number 55733A, listed by Brainlab SE, Germany, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

NaviNetics Skull Anchor Extended Screw Kit

Catalogue number NN1700, listed by Navinetics Inc., United States, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Neuro|mate® – Frameless Head-Holder – Clip

A part of the Frameless Head-holder kit, the clip fixes the Head-holder ring onto the head-holder attachment.

Neurological Stereotaxic Instrument

Guide 2.3 Biopsy Ui

Catalogue number 55983-01, listed by Brainlab SE, Germany, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Drill Guide Tube 2.4 150 Mm

Catalogue number 41839-27, listed by Brainlab SE, Germany, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Universal Tracker 2

Universal Tracker 2 for Navient

Neurological Stereotaxic Instrument

Ultrasound Clamp Aloka Ust 5268p-5

Catalogue number 41860-1, listed by Brainlab SE, Germany, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Microtargeting™ STar™ Inerstion Tube Set

microTargeting STar Array Electrode Insertion Tube Set, Sterile, for use with Nexframe and STar Drive. Contains: IT(DB7): Insertion Tube - 208mm tube length, 1.83mm od, 1.6mm id. PT(DB7):…

Neurological Stereotaxic Instrument

Ultrasound Adapter Ge 8C-Rs

Catalogue number 41860-38, listed by Brainlab SE, Germany, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Inst RND Peek ADP Ø2.15MM

"PEEK INSTRUMENT ADAPTOR Ø2.15MM instrument Rosa One 3.1 (brain application) instrument adaptor designed for guidance of biopsy needles, stimulation or recording electrodes"

Neurological Stereotaxic Instrument

Stryker Spheres – 20 CT Blister BOX

Catalogue number 02147-001, listed by IZI Medical Products LLC, United States, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Us Clamp Siemens P8-3 & 7,5 Pl13 Rev.02

Catalogue number 41860-12, listed by Brainlab SE, Germany, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Instrument Holder S

Instrument Holder S holds an Instrument Adaptor to guide the Surgical Path. A Thumb Screw connects it to the Instrument Holder Interface, and a Set Screw connects it to the Instrument…

Neurological Stereotaxic Instrument

Us Adapter Sonosite P10

Catalogue number 41860-29, listed by Brainlab SE, Germany, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Igs Probe 5.5mm Ulrich Tangors

Catalogue number 55830-64, listed by Brainlab SE, Germany, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Inst RND Peek ADP Ø4.6MM

"PEEK INSTRUMENT ADAPTOR Ø4.6MM instrument Rosa One 3.1 (brain application) instrument adaptor designed for guidance of biopsy needles, stimulation or recording electrodes"

Neurological Stereotaxic Instrument

Navsuite

NavSuite3 Kit

Neurological Stereotaxic Instrument

Surgical Equipment Drape Packs

It is used to maintain the sterility of the Trolley during the surgical procedure.

Neurological Stereotaxic Instrument

Zeta Navigation System

The Zeta Navigation System is a stereotactic, image-guided planning and intraoperative guidance system enabling computer-assisted cranial surgical procedures. The system assists surgeons in…

Neurological Stereotaxic Instrument

4mm X 120mm Schanz Screw, Qty: 10

Catalogue number KIT0284-03, listed by Mazor Robotics Ltd., Israel, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Microtargeting™ Insertion Tube and Stylet

microTargeting Insertion Tube with Stylet, Sterile

Neurological Stereotaxic Instrument

Ortho-KEY

Navigation Markers - Snap, Manufactured for ORTHO-KEY

Neurological Stereotaxic Instrument

Headholder Clamp IOP Imaging

Catalogue number 19147-01A, listed by Brainlab SE, Germany, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Brainlab Elements – Trajectory Planning

Catalogue number 2.6, listed by Brainlab SE, Germany, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Instrument Adaptor (5.2 Mm)

Instrument Adaptor has one pin screw for equipping with a Standard Neurosurgical Instrument directly. Instrument Adaptors have holes with different diameters. This model of Adaptor has an…

Neurological Stereotaxic Instrument

Reference Array Y-Geometry, X-Press

Catalogue number 52411A, listed by Brainlab SE, Germany, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Peek Instrument Adaptor Ø2,8MM

"PEEK INSTRUMENT ADAPTOR Ø2,8MM instrument Rosa One 3.1 (brain application) instrument adaptor designed for guidance of biopsy needles, stimulation or recording electrodes"

Neurological Stereotaxic Instrument

Ultrasound Clamp Hitachi Eupl 34t

Catalogue number 41860-19, listed by Brainlab SE, Germany, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Guide 3.5 Biopsy Ui

Catalogue number 55994-01, listed by Brainlab SE, Germany, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Auto-REG Matrix iMRI

Catalogue number 19208-01, listed by Brainlab SE, Germany, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Drill Guide Ao Bone Drill 2.4 Mm

Catalogue number 41839-29, listed by Brainlab SE, Germany, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Microtargeting™ Controller Power Assist System

microTargeting(TM) Controller Power Assist System for use with mT Drive or STar Drive M/E

Neurological Stereotaxic Instrument

Igsonic Adapter Base for 10v5

Catalogue number 22594, listed by Brainlab SE, Germany, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Varioguide Joint2: Telescope+Arrayholder

Catalogue number 55950-50, listed by Brainlab SE, Germany, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Starlink Suction Tube Frazier-Tip 70° Angled 8 FR

Catalogue number 55790-55, listed by Brainlab SE, Germany, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Inomed Adapter

inomed Adapter for microTargeting™ Platform

Neurological Stereotaxic Instrument

WayPoint™ Hex Wrench

WayPoint Hex Wrench

Neurological Stereotaxic Instrument

K-Wires 2.0×120 W/stop, 5 Pack

Catalogue number KIT0264-02, listed by Mazor Robotics Ltd., Israel, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

Microtargeting™ Electrode Carrier

Array Electrode Carrier for microTargeting(TM) Drive

Neurological Stereotaxic Instrument

Neuro|mate® – MRI Localizer

The imaging localizer is attached to the temporary implant insert when the patient goes into the MRI scanner for use in the ultrasound Frameless mode. Delivered in a storage case.

Neurological Stereotaxic Instrument

Guidance

12"Laser Reticle

Neurological Stereotaxic Instrument

ShuntPointer

The product ShuntPointer is a product variant for the navigation of neurosurgical shunt placement. The instruments are accessories to the Fiagon Navigation system. The Navigation system is…

Neurological Stereotaxic Instrument

SIES-Long Tapered Drill 3×80,5 Pack

Catalogue number KIT0715-01, listed by Mazor Robotics Ltd., Israel, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Neurological Stereotaxic Instrument

7.65x14mm Arm Tube

Catalogue number MAS1727-02, listed by Mazor Robotics Ltd., Israel, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer