Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3041276509

FEI Number

3041276509

Entity Name

BK ELECTRONICS CO.,LTD

City/State/Country

Anyang-si Gyeonggi, KR

Establishment Address

8F, 11F, 88, Iljik-ro, Manan-gu,, Anyang-si Gyeonggi 13901, KR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BK ELECTRONICS CO.,LTD (Owner Number: 10094012)

Owner / Operator Contact Address

8F, 11F, 88, Iljik-ro, Manan-gu, Anyang-si, KR-41 13901, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CUVIS-spine CUVIS-spine

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-09-10
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-09-10

Official Correspondent

Byeong Kwan Ra

US Agent Details

Joyce Kwon Business: PROVISION CONSULTING GROUP, INC. Email: ask@provisionfda.com Phone: (909) 4933276

Related Public Records

Same Entity

BK ELECTRONICS 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
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3041276509. Last updated year: 2026. Please use registration number 3041276509 when referencing this establishment in official correspondence.