Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025266

FEI Number

1000126034

Entity Name

SIMPEX MEDICAL, INC.

City/State/Country

Fort Mill, SC, US

Establishment Address

1974 Carolina Place Drive, Suite 216-A, Fort Mill, SC 29708, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

SIMPEX MEDICAL, INC. (Owner Number: 9002476)

Owner / Operator Contact Address

2780 Disney Place, --, Fort Mill, SC 29707, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K911505

PMA Number

N/A

All Registered Proprietary Names

Drill Bit Round Shank Drill Bit K-Wire Kirschner Wire

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2011-12-16
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2008-01-03

Official Correspondent

RICHARD GORSKI

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SIMPEX MEDICAL, 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
K895079	Buckman Co., Inc.	ACE BEADED K-WIRES ACE OLIVE WIRES	1989-09-13
K922193	Osteo AG	OSTEO KIRSCHNER WIRE	1992-07-23
K850026	Kirkstil Corp., Inc.	ORTHOPEDIC IMPLANT NAILS & PINS	1985-05-20
K963367	Rms Div.	RMS K-WIRE	1996-10-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-05	Biomet, Inc.	2	Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.

Similar Registrations

Registration Number	Establishment Name	Location
3005706667	TURNER MEDICAL INC.	Athens, AL, US
3011577940	Titan Spine, a Division of Medtronic	Milwaukee, WI, US
2031917	CLASSIC WIRE CUT COMPANY, INC.	Valencia, CA, US
3003431869	HILBRO INTERNATIONAL (PVT) LIMITED	SIALKOT Punjab, PK
3023265483	PHEN'X TECHNOLOGIES	Chassieu Auvergne-Rhone-Alpes, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025266. Last updated year: 2026. Please use registration number 3025266 when referencing this establishment in official correspondence.