Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002250546

FEI Number

3002250546

Entity Name

FHC, INC.

City/State/Country

Bowdoin, ME, US

Establishment Address

1201 MAIN ST, Bowdoin, ME 04287, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FHC, Inc. (Owner Number: 9037838)

Owner / Operator Contact Address

1201 Main St., --, Bowdoin, ME 04287, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K012366

PMA Number

N/A

All Registered Proprietary Names

Nexprobe microTargeting Electrode 1(electrode type)2(material with insulation)3(impedance)4(sterility)(x)(y)variations Passive Headrest microTargeting Drive System Acc. WayPoint Stereotactic System microTargeting XL STar Drive System microTargeting(TM) Guideline 4000(TM) 5 System VFS1 Bipolar Electrosurgical Generator NexDrive Visualase Anchor Bolt Removal Tool DP Stylet 5x 204mm Visualase Anchor Bolt Tools Visualase Driver Guide for CRW Visualase Neuro Accessories Visualase Driver Guide for Leksell Visualase Sterilization & Storage Tray Visualase Driver Guide for ROSA ONE Visualase Driver Guide for Autoguide Visualase Anchor Bolt Driver STarFix Designer Software microTargeting STar Drive System NexFrame

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2020-10-15
GZL	Electrode, Depth	Neurology	Class 2	882.1330	2007-11-06
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	Class 2	882.4460	2020-10-15
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2007-11-06
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2010-02-26
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2012-12-13
GZL	Electrode, Depth	Neurology	Class 2	882.1330	2018-12-31
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-07-10
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2020-10-15
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2015-03-06
QRI	Surgical Planning Software For Neurological Stereotaxic Instruments	Neurology	Class 2	882.4560	2023-09-11
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-09-11
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2009-10-14
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2020-10-15

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FHC, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005161223	FHC, Inc	Greenville, PA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K010427	Walter Lorenz Surgical, Inc.	LORENZ FIDUCAIL SCREW	2001-03-15
K812744	Progress Mankind Technology	LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER	1981-12-03
K092467	Brainlab AG	VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED	2010-05-06
K031454	Biomet, Inc.	ACUMEN SURGICAL NAVIGATION SYSTEM	2004-07-08
K071458	Integra LifeSciences Corporation	MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS	2007-06-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0002-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0005-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000.
Z-0006-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000.
Z-0007-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System Dell Model D800 laptop computers (only), Stryker # 7700-309-010 and 6000-200-064.

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3009108888	RENISHAW MAYFIELD	Chassieu Rhone, FR
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2434444	NEURODYNAMICS, INC.	Manhattan, NY, US
3017004815	RENISHAW NEURO SOLUTIONS LTD	Wotton-under-Edge Gloucestershire, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002250546. Last updated year: 2026. Please use registration number 3002250546 when referencing this establishment in official correspondence.