Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042285592

FEI Number

3042285592

Entity Name

APLUS (GUANGZHOU) MEDICAL TECHNOLOGY COMPANY

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

Room 202, No.14 Lianpu Street, Huangpu District, Guangzhou Guangdong 510555, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

APLUS (GUANGZHOU) MEDICAL TECHNOLOGY COMPANY (Owner Number: 10094445)

Owner / Operator Contact Address

Room 202, No.14 Lianpu Street, Huangpu District, Guangzhou, CN-GD 510555, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

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
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2025-12-22
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2025-12-01
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2025-12-22
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2026-04-20
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2025-12-25

Official Correspondent

CHAN MOU

US Agent Details

Fan Yang Email: earniy@grdautoparts.com Phone: (917) 6786736

Related Public Records

Same Entity

APLUS (GUANGZHOU) MEDICAL TECHNOLOGY COMPANY

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
K895079	Buckman Co., Inc.	ACE BEADED K-WIRES ACE OLIVE WIRES	1989-09-13
K922193	Osteo AG	OSTEO KIRSCHNER WIRE	1992-07-23
K850026	Kirkstil Corp., Inc.	ORTHOPEDIC IMPLANT NAILS & PINS	1985-05-20
K963367	Rms Div.	RMS K-WIRE	1996-10-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-05	Biomet, Inc.	2	Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
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

Similar Registrations

Registration Number	Establishment Name	Location
8010177	STRYKER LEIBINGER GMBH & CO. KG	FREIBURG Baden-Wurttemberg, DE
8043862	AAP IMPLANTATE AG	BERLIN, DE
3006783837	STRUCTURE MEDICAL, LLC.	Naples, FL, US
3015231789	Arthrex Manufacturing Inc.	Pendleton, SC, US
2029275	Sterigenics U.S., LLC	Corona, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042285592. Last updated year: 2026. Please use registration number 3042285592 when referencing this establishment in official correspondence.