CORIOGRAPH PRE-OP PLANNING AND MODELING SERVICE

CORIOGRAPH PRE
CORIOGRAPH - ROB20030

A 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.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PBF

Device Name: Orthopaedic Surgical Planning And Instrument Guides

Device Class: 2

Physical State: Software and hardware

Definition: As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures.

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: for pre-surgical planning including transfering, visualizing, measuring, annotating and editing medical data. Patient specific templates that are based on pre-operative plan and are designed to fit a specific patient. These guides are used to assist a surgeon in guiding the marking of bone and/or guiding surgical instruments.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: long bones

Regulation Number: 888.3030

Third Party Flag: N

Medical Specialty: OR

Code: OOG

Device Name: Knee Arthroplasty Implantation System

Device Class: 2

Physical State: A device accessory or set of device accessories;

Definition: Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Aids the surgeon in performing the implantation of the knee implant

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Knee

Regulation Number: 888.3560

Third Party Flag: N

Medical Specialty: OR

Code: MBH

Device Name: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 888.3565

Third Party Flag: N

Medical Specialty: OR

Code: JWH

Device Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 888.3560

Third Party Flag: N

Medical Specialty: OR

Code: HSX

Device Name: Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 888.3520

Third Party Flag: N

Medical Specialty: OR

Device Id: 00885556917442

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A