Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010388970

FEI Number

3010388970

Entity Name

GUANGZHOU AQUILA PRECISE TOOLS LIMITED

City/State/Country

Guangzhou City Guangdong, CN

Establishment Address

Jinsiwei Industrial Zone, Dachongkou Village, Shawan Town, Panyu District, Guangzhou City Guangdong 511483, CN

Establishment Type(s)

Manufacture Medical 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
HTQ	Broach	Orthopedic	Class 1	888.4540	2015-01-30
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2017-02-13
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-12-06
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2023-02-17
FXZ	Helmet, Surgical	General, Plastic Surgery	Class 1	878.4040	2016-11-14
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-07-14
HWT	Template	Orthopedic	Class 1	888.4800	2015-01-12
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2013-11-29
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2016-06-24
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2013-11-29
HWA	Impactor	Orthopedic	Class 1	888.4540	2016-04-08
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2014-08-07
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2017-06-01
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2017-06-01
GFG	Bit, Surgical	General, Plastic Surgery	Class 1	878.4820	2014-12-01
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2023-02-17
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2017-06-01
KTZ	Caliper	Orthopedic	Class 1	888.4150	2013-07-14
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
HRT	Stripper, Surgical	Orthopedic	Class 1	888.4540	2017-05-12

Official Correspondent

No official correspondent registered.

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
3009582259	Li Wai Precision International Limited	Tsimshatsui, Kowloon, HK

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K222566	Zimmer, Inc.	Zimmer Persona Personalized Knee System	2022-10-17
K252044	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	Triathlon® Total Knee System - Triathlon® Gold Femoral Components	2025-10-24
K243247	Zimmer, Inc.	Persona the Personalized Knee System	2024-10-29
K901338	Kirschner Medical Corp.	KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM	1990-05-22
K030577	Stelkast Company	PROVEN MODULAR TIBIAL TRAY	2003-03-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010388970. Last updated year: 2026. Please use registration number 3010388970 when referencing this establishment in official correspondence.