Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007955117

FEI Number

3007955117

Entity Name

HANCHANG CO., LTD

City/State/Country

Bucheon-si Gyeonggi, KR

Establishment Address

#301-204 Bucheon Techno-park, 345, Seokcheon-ro, Bucheon-si Gyeonggi 14501, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HANCHANG Co., Ltd (Owner Number: 10057970)

Owner / Operator Contact Address

#301-204 Bucheon Techno-park, 345, Seokcheon-ro, Bucheon-si, KR-41 14501, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K172871

PMA Number

N/A

All Registered Proprietary Names

SpineKure Kyphoplasty System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2018-06-19
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2018-06-19

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

HANCHANG 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
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.

Similar Registrations

Registration Number	Establishment Name	Location
3044858680	JIENO YOUCHENG MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD.	Shanghai, CN
3014725904	Medtronic Medical Costa Rica S.R.L.	Coyol Alajuela, CR
2648623	STERIS ISOMEDIX PUERTO RICO, INC.	Alts De Cerro Gordo 3&4, PR, US
3015309643	Merit Medical UK Limited	Earley Reading, GB
3008572623	ELMDOWN SRL UNIPERSONALE	milano Lombardy, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007955117. Last updated year: 2026. Please use registration number 3007955117 when referencing this establishment in official correspondence.