FDA.reportPublic FDA data

OPTIMIZED ORTHO PTY LTD

Matched from indexed company URL: OPTIMIZE, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30129167843012916784OPTIMIZED ORTHO PTY LTD1N2026-01-0117 Bridge Street Sydney New South Wales AU 2073
30129167843012916784OPTIMIZED ORTHO PTY LTD1N2020-04-2517 Bridge Street Sydney New South Wales AU 2073

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
09351327000848OPSInsight™ - OPSInsight™ is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.1 (772) 321-2478Lucinda.Gerber@Coringroup.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3468001227655313K202805Optimized Positioning System (OPS) InsightLLZ2020-11-20
3468001580427083K193545Corin Optimized Positioning System (OPS) FemoralLZO2020-08-04
3468001099796795K193042Optimized Positioning System (OPS) ReViewLLZ2020-06-26
3468001939188667K192656Optimized Positioning System (OPS) InsightLLZ2020-05-01
3468001320253938K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)LZO2019-07-22
1964851727645490K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)LZO2019-07-22
1964851352428132K183038Corin Optimized Positioning System (OPS) PlanLLZ2018-11-26
3468001758975999K183038Corin Optimized Positioning System (OPS) PlanLLZ2018-11-26
1964851621599010K181061Corin Optimized Positioning System (OPS) FemoralLZO2018-09-07
3468001887699286K181061Corin Optimized Positioning System (OPS) FemoralLZO2018-09-07
3468001595568229K171847Corin Optimized Positioning System (OPS™) PlanLLZ2018-04-05
1964851878641924K171847Corin Optimized Positioning System (OPS™) PlanLLZ2018-04-05
3468001117972777K152893Corin Optimized Positioning System (OPS)LZO2016-06-03
1964851406630074K152893Corin Optimized Positioning System (OPS)LZO2016-06-03
3468001668979650

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ72020-11-20
LZO72020-08-04

PMN#

GUDID#

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