Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013588740

FEI Number

3013588740

Entity Name

Osseointegration International Pty Ltd

City/State/Country

Macquarie Park New South Wales, AU

Establishment Address

Suite 6.02, 11 Khartoum Road, Macquarie Park New South Wales 2113, AU

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Osseointegration International Pty Ltd (Owner Number: 10059064)

Owner / Operator Contact Address

Suite 6.02, 11 Khartoum Road, Macquarie Park, AU-NSW 2113, AU

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
IQO	Device, Prosthesis Alignment	Physical Medicine	Class 1	890.3025	2019-11-05
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2018-11-27
KFX	Assembly, Thigh/Knee/Shank/Ankle/Foot, External	Physical Medicine	Class 2	890.3500	2019-01-30

Official Correspondent

William Lu

US Agent Details

Renee Zamani Business: Osseointegration International Inc Email: accounts@osseointernational.com Phone: (646) 6470600

Related Public Records

Same Entity

Osseointegration International Pty Ltd

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

View Entity Profile →

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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1022826	FILLAUER, LLC	CHATTANOOGA, TN, US
3004646509	REGAL PROSTHESIS LIMITED	Kwai Chung NT, HK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013588740. Last updated year: 2026. Please use registration number 3013588740 when referencing this establishment in official correspondence.