Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014346934

FEI Number

3014346934

Entity Name

BioGend Therapeutics Co., Ltd

City/State/Country

Taipei City, TW

Establishment Address

4F., No.3-2, Park St., Nangang Dist.,, Taipei City 11503, TW

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

BioGend Therapeutics Co., Ltd. (Owner Number: 10048901)

Owner / Operator Contact Address

4F, 3-2 Park Street, Nangang District, Taipei City, TW-TPE 11503, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233075

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-03-19

Official Correspondent

No official correspondent registered.

US Agent Details

STEVE LIN Email: stclin@gmail.com Phone: (352) 5143922

Related Public Records

Same Entity

BioGend Therapeutics Co., Ltd.

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
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05
K193541	Nu Vasive, Incorporated	NuVasive Cohere Thoracolumbar Interbody System	2020-03-30
K080401	Advanced Medical Technologies AG	SHELL CAGE, WAVE CAGE, LOOP CAGE	2008-05-09
K200084	Zavation Medical Products, LLC	Zavation IBF System	2020-10-19

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014346934. Last updated year: 2026. Please use registration number 3014346934 when referencing this establishment in official correspondence.