FDA.reportPublic FDA data

OPSInsight™

Primary DI
09351327000848
Brand
OPSInsight™
Company
OPTIMIZED ORTHO PTY LTD
Model
1.2
Catalog number
1200-0000
Device description
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.
Published
2021-03-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202805000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202805000Optimized Positioning System (OPS) InsightCorin USA2020-11-20LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09351327000848PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09351327000848093513270008489351327000848

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic/craniofacial implantation planning softwareA software program intended to add specific computer-assisted display, processing, and/or analysis capabilities to prepare for the implantation of an orthopaedic and/or craniomaxillofacial (CMF) prosthesis. Using digitized x-rays or imported computed tomography (CT) images, it provides implant-site anatomical images, and using computerized files representing implant patterns, provides the surgeon with images that help determine the appropriate size and placement of the implant.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 (772) 321-2478Lucinda.Gerber@Coringroup.com

Regulatory Flags#

DUNS number
745735175
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09351327000374OPS™ FHA1205-00012019-11-11
09351327000077Optimized Positioning System (OPS) Plan1250-13002019-04-23
09351327000091Optimized Positioning System (OPS) Plan 1250-1300 2019-04-23
09351327001302Optimized Ortho Positioning (OPS) System1248-50002022-05-26
09351327001364Optimized Ortho Positioning (OPS) System1248-50012022-05-26
09351327000022Optimized Positioning System (OPS)1248-1500 and 1248-17002019-04-18
09351327000053Optimized Positioning System (OPS) and Optimized Postioning System (OPS) Femoral1248-1500, 1248-1700, 1250-11002019-04-18
09351327000060Optimiized Positioning System(OPS) and Optimized Postioning System(OPS)Femoral1248-1500, 1248-1700, 1250-1100,1250-12002019-04-18
09351327000084Optimized Positioning System (OPS) Femoral 1250-1100,1250-12002019-04-18
09351327000008Optimized Ortho Positioning (OPS) System 1248-15002019-04-12
09351327000015Optimized Ortho Positioning (OPS) System 1248-17002019-04-12
09351327000039Optimized Ortho Positioning (OPS) Femoral1250-11002019-04-12
09351327000046Optimized Ortho Positioning (OPS) Femoral1250-12002019-04-12
09351327000695OPS1248-00722020-02-17
09351327000701OPS1248-00412020-02-17
09351327000718OPS1248-00422020-02-17
09351327000725OPS1248-00432020-02-17
09351327000732OPS1248-00762020-02-17
09351327000749OPS1248-00772020-02-17
09351327000756OPS1248-00832020-02-17

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Primary DI, Brand, Company table
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