Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042969807

FEI Number

3042969807

Entity Name

INNOORTHO CO., LTD.

City/State/Country

Sejong Special Self-Governing City, KR

Establishment Address

Bodeum 7-ro, 20, 6th floor, Room 607, Sejong Special Self-Governing City 30099, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

InnoOrtho Co., Ltd. (Owner Number: 10094621)

Owner / Operator Contact Address

Bodeum 7-ro, 20, 6th floor, Room 607, Sejong Special Self-Governing City, KR-50 30099, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

WIOR Wrench Star 450 WIOR Wrench Star Tip 350 WIOR Wrench Star 250 WIOR Wrench Hexa Tip 500 WIOR Wrench Hexa 350 WIOR Handle WIOR Wrench Hexa Tip 450 WIOR Wrench Star Tip 450 WIOR Wrench Star 350 WIOR Wrench Hexa Tip 250 WIOR Wrench Star 500 WIOR Wrench Star Tip 500 WIOR Body 4550 WIOR Wrench Star Tip 250 WIOR Wrench Hexa 500 WIOR Body 2535 WIOR Wrench Hexa 450 WIOR Wrench Hexa Tip 350 WIOR Wrench Hexa 250

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2025-12-11

Official Correspondent

Jeong-Kil Lee

US Agent Details

Uju Krallum Business: Onbix Corp US Email: ONBIXUS@GMAIL.COM Phone: (843) 5828036

Related Public Records

Same Entity

InnoOrtho Co., Ltd.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042969807. Last updated year: 2026. Please use registration number 3042969807 when referencing this establishment in official correspondence.