Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2183456

FEI Number

2183456

Entity Name

AD-TECH MEDICAL INSTRUMENT CORP.

City/State/Country

Oak Creek, WI, US

Establishment Address

400 West Oakview Parkway, Oak Creek, WI 53154, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AD-TECH MEDICAL INSTRUMENT CORP. (Owner Number: 2183456)

Owner / Operator Contact Address

400 West Oakview Parkway, --, Oak Creek, WI 53154, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K112094

PMA Number

N/A

All Registered Proprietary Names

LSB Anchor Bolt Dual-Sided Subdural Electrodes Grid Subdural Electrodes Strip Subdural Electrodes Intraoperative Subdural Electrodes Ad-Tech Subdural Electrodes Wyler Subdural Electrodes Ad-Tech Depth Electrodes Cranial Drill Bits and Accessories Ad-Tech Removal Wrench Ad-Tech Placement Wrench Ad-Tech Brain Biopsy Needles Ad-Tech Obturators WYLER TRANSECTOR Ad-Tech Depth Electrodes Spencer Probe Electrodes Sphenoidal Electrodes Macro-Micro Depth Electrodes Foramen Ovale Electrodes Cueva Cranial Nerve Electrodes DNAP Electrode Ad-Tech Passing Needles Ad-Tech Pin Crimper FREMAP Electrode Brain Biopsy Needle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GZL	Electrode, Depth	Neurology	Class 2	882.1330	2024-12-04
GYC	Electrode, Cortical	Neurology	Class 2	882.1310	2024-12-04
GZL	Electrode, Depth	Neurology	Class 2	882.1330	2024-12-04
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Neurology	Class 2	882.4310	2018-01-09
HBG	Drills, Burrs, Trephines & Accessories (Manual)	Neurology	Class 2	882.4300	2018-01-09
HXC	Wrench	Orthopedic	Class 1	888.4540	2007-11-12
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2007-11-12
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2001-04-25
GZL	Electrode, Depth	Neurology	Class 2	882.1330	2018-02-28
GZL	Electrode, Depth	Neurology	Class 2	882.1330	2007-11-12
GZL	Electrode, Depth	Neurology	Class 2	882.1330	2016-09-06
GYC	Electrode, Cortical	Neurology	Class 2	882.1310	2016-09-06
HWQ	Passer	Orthopedic	Class 1	888.4540	2007-11-12
HXQ	Crimper, Pin	Orthopedic	Class 1	888.4540	2007-11-12
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2016-09-06
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2013-01-04
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2013-01-04

Official Correspondent

Frederick Guesneau

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AD-TECH MEDICAL INSTRUMENT CORP.

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

View Entity Profile →

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
K833646	Edward Weck, Inc.	PULSATRON NERVE LOCATOR/STIMULATOR	1984-02-10

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2183456. Last updated year: 2026. Please use registration number 2183456 when referencing this establishment in official correspondence.