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Optimized Ortho Pty Ltd: FDA-registered device maker in Sydney New South Wales, Australia, 6 510(k) clearances

Name: Optimized Ortho Pty Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Optimized Ortho Pty Ltd is registered with the FDA (registration 3012916784) in Sydney New South Wales, Australia. It lists 7 device types. The FDA files 6 510(k) clearances under its listings, the newest dated November 20, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012916784
Address: 17 Bridge Street, Sydney New South Wales, Australia, 2073
Owner or operator: Corin Group (9012268)
Roles: Exporter to the US, Manufacturer, Specification developer
First device listed: August 13, 2007
Registered through: 2026
Brand names listed: Optimized Positioning System (OPS), Optimized Positioning System (OPS) Femoral, Optimized Positioning System (OPS) Insight, Optimized Positioning System (OPS) ReView, Surgical Instrument

Devices it lists

Device	Product code	Class	Role	Source
Acetabular Cup Orientation System	PLW	2	Manufacturer	accessdata.fda.gov
Orthopaedic Surgical Planning And Instrument Guides	PBF	2	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Exporter to the US, Specification developer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	LZO	2	Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	LWJ	2	Manufacturer	accessdata.fda.gov
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	MEH	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 20, 2020	K202805	Optimized Positioning System (OPS) Insight	LLZ	Substantially Equivalent	Corin USA	accessdata.fda.gov
August 4, 2020	K193545	Corin Optimized Positioning System (OPS) Femoral	LZO	Substantially Equivalent	Corin USA	accessdata.fda.gov
June 26, 2020	K193042	Optimized Positioning System (OPS) ReView	LLZ	Substantially Equivalent	Corin USA	accessdata.fda.gov
May 1, 2020	K192656	Optimized Positioning System (OPS) Insight	LLZ	Substantially Equivalent	Corin USA	accessdata.fda.gov
September 7, 2018	K181061	Corin Optimized Positioning System (OPS) Femoral	LZO	Substantially Equivalent	Corin USA	accessdata.fda.gov
June 3, 2016	K152893	Corin Optimized Positioning System (OPS)	LZO	Substantially Equivalent	Corin USA	accessdata.fda.gov

Compare with other makers

Updated November 20, 2020. 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.