Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011569539

FEI Number

3011569539

Entity Name

MCGINLEY ORTHOPAEDIC INNOVATIONS, INC

City/State/Country

Casper, WY, US

Establishment Address

234 E. 1st Street, Ste 242, Casper, WY 82601, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

McGinley Orthopaedic Innovations, INC (Owner Number: 10048881)

Owner / Operator Contact Address

234 E 1st Street, Suite 242, Casper, WY 82601, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IntelliSense Drill Lever Action Plate System Universal Chuck Set for the IntelliSense Drill System McGinley AR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2015-03-16
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2015-03-16
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2015-03-16
GFG	Bit, Surgical	General, Plastic Surgery	Class 1	878.4820	2015-03-16
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-07-20
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2016-05-04
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2019-02-26

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

McGinley Orthopaedic Innovations, INC

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
K905383	Micro Surgical Instruments Corp.	2710-000 OSCILLATING SAW, GENERAL ASSEMBLY	1991-06-18
K913369	Micro Surgical Instruments Corp.	MICRO-AIRE MODEL 2060	1991-11-01
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

Similar Registrations

Registration Number	Establishment Name	Location
3014725904	Medtronic Medical Costa Rica S.R.L.	Coyol Alajuela, CR
3040335671	Stryker Ireland Ltd. Instruments Division, Innovation Centre	Carrigtwohill Cork (County), IE
3010363503	FRUEH VERPACKUNGSTECHNIK AG	Fehraltorf Zurich, CH
3010287737	BAECHLER FEINTECH AG	Hoelstein Basel-Landschaft, CH
3010673850	MK medical GmbH	Emmingen-Liptingen Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011569539. Last updated year: 2026. Please use registration number 3011569539 when referencing this establishment in official correspondence.