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Data / Medical devices / Hong Kong / Li Wai Precision International Limited

Li Wai Precision International Limited: FDA-registered device maker in Tsimshatsui, Kowloon, Hong Kong, 4 510(k) clearances

Li Wai Precision International Limited is registered with the FDA (registration 3009582259) in Tsimshatsui, Kowloon, Hong Kong. It lists 28 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 1, 2016. Registered through 2027. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Li Wai Precision International Limited
FDA registration number
3009582259
Address
RM 1804, 18/F, Cheuk Nang Centre, No. 9 Hillwood Road, Tsimshatsui, Kowloon, Hong Kong, 00000
Owner or operator
Guangzhou Aquila Precise Tools Limited (10044682)
Roles
Contract manufacturer, Exporter to the US, Manufacturer
First device listed
July 14, 2013
Registered through
2027

Devices it lists

DeviceProduct codeClassRoleSource
Bit, DrillHTW1Exporter to the USaccessdata.fda.gov
Bit, SurgicalGFG1Exporter to the USaccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Exporter to the USaccessdata.fda.gov
Bone MillLYS1Exporter to the USaccessdata.fda.gov
BroachHTQ1Exporter to the USaccessdata.fda.gov
CaliperKTZ1Exporter to the USaccessdata.fda.gov
Driver, ProsthesisHWR1Exporter to the USaccessdata.fda.gov
Driver, Surgical, PinGFC1Exporter to the USaccessdata.fda.gov
ExtractorHWB1Exporter to the USaccessdata.fda.gov
ForcepsHTD1Exporter to the USaccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Exporter to the USaccessdata.fda.gov
Helmet, SurgicalFXZ1Exporter to the USaccessdata.fda.gov
ImpactorHWA1Exporter to the USaccessdata.fda.gov
Instrument, Cutting, OrthopedicHTZ1Exporter to the USaccessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentHWE1Exporter to the USaccessdata.fda.gov
Instruments Designed For Press-Fit Osteochondral ImplantsQBO2Exporter to the USaccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Exporter to the USaccessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedLPH2Exporter to the USaccessdata.fda.gov
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerMBH2Exporter to the USaccessdata.fda.gov
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH2Exporter to the USaccessdata.fda.gov
Punch, SurgicalLRY1Exporter to the USaccessdata.fda.gov
RaspHTR1Exporter to the USaccessdata.fda.gov
ReamerHTO1Contract manufacturer, Manufactureraccessdata.fda.gov
ScrewdriverHXX1Exporter to the USaccessdata.fda.gov
Stripper, SurgicalHRT1Exporter to the USaccessdata.fda.gov
Tap, BoneHWX1Exporter to the USaccessdata.fda.gov
TemplateHWT1Exporter to the USaccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Exporter to the USaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 1, 2016K160895Initia Total Hip System & BIOCERAM AZUL(R) HEADLZOSubstantially EquivalentKyocera Medical Corporationaccessdata.fda.gov
November 9, 2012K122765PERSONA NATURAL TIBIA BASEPLATESJWHSubstantially EquivalentZimmer, Inc.accessdata.fda.gov
March 27, 2012K113369ZIMMER PERSONA KNEE SYSTEMJWHSubstantially EquivalentZimmer, Inc.accessdata.fda.gov
October 9, 2003K031061NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTSMBHSubstantially EquivalentZimmer, Inc.accessdata.fda.gov

Compare with other makers

Updated November 1, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.