Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009582259

FEI Number

3009582259

Entity Name

Li Wai Precision International Limited

City/State/Country

Tsimshatsui, Kowloon, HK

Establishment Address

RM 1804, 18/F, Cheuk Nang Centre, No. 9 Hillwood Road,, Tsimshatsui, Kowloon 00000, HK

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Guangzhou Aquila Precise Tools Limited (Owner Number: 10044682)

Owner / Operator Contact Address

RM 1804, Cheuk Nang Centre, 9 Hillwood Road, Tsim Sha Tsui, Kowloon, HK-NOTA 00000, HK

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
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2017-02-13
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2014-08-07
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2016-06-24
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2017-03-02
HWB	Extractor	Orthopedic	Class 1	888.4540	2016-10-11
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-12-06
HWA	Impactor	Orthopedic	Class 1	888.4540	2016-04-08
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2017-08-22
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2023-02-17
FXZ	Helmet, Surgical	General, Plastic Surgery	Class 1	878.4040	2016-11-14
HRT	Stripper, Surgical	Orthopedic	Class 1	888.4540	2017-05-12
KTZ	Caliper	Orthopedic	Class 1	888.4150	2013-07-14
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2013-12-06
GFC	Driver, Surgical, Pin	General, Plastic Surgery	Class 1	878.4820	2013-07-14
LYS	Bone Mill	Orthopedic	Class 1	888.4540	2017-06-22
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-07-14
QBO	Instruments Designed For Press-Fit Osteochondral Implants	Orthopedic	Class 2	888.4505	2025-06-17
HTQ	Broach	Orthopedic	Class 1	888.4540	2015-01-30
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2014-12-01
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2017-06-01
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2023-02-17

Official Correspondent

Angela Chan

US Agent Details

Marissa Vilchez Email: m.vilchez@mdssar.com Phone: (312) 9751694

Related Public Records

Same Entity

Guangzhou Aquila Precise Tools Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010388970	GUANGZHOU AQUILA PRECISE TOOLS LIMITED	Guangzhou City Guangdong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K860442	Howmedica Corp.	PRECISION HIP SYSTEM PROXIMAL FEMORAL SPACER #6259	1986-05-06
K973124	Sulzer Orthopedics, Inc.	APR POROUS HA HIP SYSTEM	1997-11-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009582259. Last updated year: 2026. Please use registration number 3009582259 when referencing this establishment in official correspondence.