OPSInsight™ 1200-0000

GUDID 09351327000848

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.

OPTIMIZED ORTHO PTY LTD

Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software
Primary Device ID09351327000848
NIH Device Record Key23766a43-c426-4b4a-9646-d4dd77ae8c11
Commercial Distribution StatusIn Commercial Distribution
Brand NameOPSInsight™
Version Model Number1.2
Catalog Number1200-0000
Company DUNS745735175
Company NameOPTIMIZED ORTHO PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1 (772) 321-2478
EmailLucinda.Gerber@Coringroup.com
Phone1 (772) 321-2478
EmailLucinda.Gerber@Coringroup.com
Phone1 (772) 321-2478
EmailLucinda.Gerber@Coringroup.com
Phone1 (772) 321-2478
EmailLucinda.Gerber@Coringroup.com
Phone1 (772) 321-2478
EmailLucinda.Gerber@Coringroup.com
Phone1 (772) 321-2478
EmailLucinda.Gerber@Coringroup.com
Phone1 (772) 321-2478
EmailLucinda.Gerber@Coringroup.com
Phone1 (772) 321-2478
EmailLucinda.Gerber@Coringroup.com
Phone1 (772) 321-2478
EmailLucinda.Gerber@Coringroup.com
Phone1 (772) 321-2478
EmailLucinda.Gerber@Coringroup.com
Phone1 (772) 321-2478
EmailLucinda.Gerber@Coringroup.com
Phone1 (772) 321-2478
EmailLucinda.Gerber@Coringroup.com
Phone1 (772) 321-2478
EmailLucinda.Gerber@Coringroup.com
Phone1 (772) 321-2478
EmailLucinda.Gerber@Coringroup.com
Phone1 (772) 321-2478
EmailLucinda.Gerber@Coringroup.com
Phone1 (772) 321-2478
EmailLucinda.Gerber@Coringroup.com

Device Identifiers

Device Issuing AgencyDevice ID
GS109351327000848 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-24
Device Publish Date2021-03-16

Devices Manufactured by OPTIMIZED ORTHO PTY LTD

09351327001302 - Optimized Ortho Positioning (OPS) System2022-06-03 OPS Reusable Instrument Inner Tray
09351327001364 - Optimized Ortho Positioning (OPS) System2022-06-03 OPS Reusable Instrument Outer Tray with Lid
09351327000848 - OPSInsight™2021-03-24OPSInsight™ is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.
09351327000848 - OPSInsight™2021-03-24 OPSInsight™ is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection,
09351327000695 - OPS2020-02-25 Impactor Canister Adaptor 42.5mm
09351327000701 - OPS2020-02-25 Right Angle Clamp
09351327000718 - OPS2020-02-25 Reference Arm Short
09351327000725 - OPS2020-02-25 Reference Arm Long
09351327000732 - OPS2020-02-25 Short Curved Guide Handle

Trademark Results [OPSInsight]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OPSINSIGHT
OPSINSIGHT
87004801 not registered Live/Pending
Rosemount Aerospace Inc.
2016-04-18
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