Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017823294

FEI Number

3017823294

Entity Name

REMEX MEDICAL CORP.

City/State/Country

Taichung, TW

Establishment Address

4F., No. 9, Jingke Road, Nantun Dist., Taichung 408224, TW

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Remex Medical Corp. (Owner Number: 10078678)

Owner / Operator Contact Address

4F., No. 9, Jingke Road, Nantun Dist., Taichung, TW-NOTA 408209, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243560

PMA Number

N/A

All Registered Proprietary Names

Remex Spine Surgery Navigation System II WatchTower spine navigation system Drill bit Anatase spine navigation instrument WatchTower spine navigation instrument Releaser Bone Pin Guide Pin 540L Slide hammer WatchTower spine navigation instrument Driver Anatase spine navigation instrument WatchTower Spine Navigation System Anatase Spine Surgery Navigation System WatchTower spine navigation instrument Post Wrench Hex Key Wrench #3 Hex Key Wrench #2 Anatase spine navigation instrument Anatase Surgery Navigation System WatchTower Spine Navigation System Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II WatchTower Spine Navigation Instrument Remex Spine Surgery Navigation Instrument

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-05-05
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2022-10-31
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2022-10-31
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-04-23
HXC	Wrench	Orthopedic	Class 1	888.4540	2022-10-31
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2020-11-01
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-11-24
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-12-16

Official Correspondent

Jessie Wang

US Agent Details

Travis Hsu Business: Qualtech Consulting LLC Email: travis@qualtechs.com Phone: (626) 3455899

Related Public Records

Same Entity

Remex Medical Corp.

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
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

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3018405359	A7 INTEGRATION	Granby Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017823294. Last updated year: 2026. Please use registration number 3017823294 when referencing this establishment in official correspondence.