Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010764965

FEI Number

3010764965

Entity Name

BIC TOOL JAPAN

City/State/Country

SAIHAKUGUN Tottori, JP

Establishment Address

38, Hiezu, Hiezuson,, SAIHAKUGUN Tottori 689-3553, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BIC TOOL JAPAN (Owner Number: 10091234)

Owner / Operator Contact Address

38, Hiezu, Hiezuson,, SAIHAKUGUN, JP-31 689-3553, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NO BRAND NAME

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2024-07-29

Official Correspondent

Mariko Mukushina

US Agent Details

Drew Weaver Business: Ortho Development Corp. Email: dweaver@orthodevelopment.com Phone: (801) 5539991

Related Public Records

Same Entity

BIC TOOL JAPAN

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3013011598	MAHE MEDICAL USA	Laramie, WY, US
3007728266	SPINEART SA	Plan-les-Ouates Geneve, CH
1226191	Tegra Medical - Franklin, MA	Franklin, MA, US
3038187464	MIRACLUS ORTHOTECH PRIVATE LIMITED	Ahmedabad Gujarat, IN
3002808227	SOR VAN RADIATION LTD	Yavne Tel Aviv, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010764965. Last updated year: 2026. Please use registration number 3010764965 when referencing this establishment in official correspondence.