Who else makes this device?

Name: Brain Surgical Acc. Intra-operative Kit
Brand: Brain Surgical Acc. Intra-operative Kit

Neurology › SurgicalNeurological Stereotaxic Instrument

Brain Surgical Acc. Intra-Operative Kit

Catalogue number KIT0295-10, listed by Mazor Robotics Ltd., Israel, under Neurological Stereotaxic Instrument. 5 manufacturers in China are registered for this product code.

Registry build 21.09.26

5manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

1recall

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.

Chinese manufacturers registered for FDA product code HAW
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

Regulatory record for Brain Surgical Acc. Intra-operative Kit
Listed by	Mazor Robotics Ltd., Israel
FDA product code	HAW
Device type	Neurological Stereotaxic Instrument
Device class	Class 2
Regulation	21 CFR 882.4560
Establishment	Specification developer, Manufacturer
Record published	2020-02-19
Record revised	2024-03-13 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Supplied as a kit	Yes
Label carries	lot or batch number, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Brain Surgical Acc. Intra-operative Kit
Catalogue number	Size	Status
KIT0295-10		In distribution

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
Clearance	Decision date
K120812	2012-07-12
K113228	2011-12-01
K110911	2011-04-28

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.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2014-11-26	Class II	Device Design	In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move.	5 units	2019-07-03

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.