Who else makes this device?

Name: Instrument Holder S Set
Brand: Instrument Holder S Set

Neurology › SurgicalNeurological Stereotaxic Instrument

Instrument Holder S Set

Contains the following: 1 x Instrument Holder S (FPIH0011) 1 x Instrument Adaptor (3mm) (COIH0301) 1 x Instrument Adaptor (5mm) (COIH0303) 1 x Instrument Adaptor (8mm) (COIH0304) 1 x…

Registry build 21.09.26

Contains the following: 1 x Instrument Holder S (FPIH0011) 1 x Instrument Adaptor (3mm) (COIH0301) 1 x Instrument Adaptor (5mm) (COIH0303) 1 x Instrument Adaptor (8mm) (COIH0304) 1 x Catheter Adaptor (3.5mm) (FPIH0401) 1 x SEEG Adaptor (FPIH0310) 1 x Set Screw of Instrument Holder (COSC3012) 6 x Pin Screw of Instrument Adaptor (COSC3002) 1 x Thumb Screw of Instrument Holder (COSC6011)

5manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

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 Instrument Holder S Set
Listed by	Brain Navi Biotechnology Co., Ltd., Taiwan
FDA product code	HAW
Device type	Neurological Stereotaxic Instrument
Device class	Class 2
Regulation	21 CFR 882.4560
Establishment	Manufacturer
Record published	2026-07-25

Specifications

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

Catalogue Numbers

Catalogue numbers for Instrument Holder S Set
Catalogue number	Size	Status
FPIH1172		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
K242575	2025-05-23

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.