CORIOGRAPH Pre
CORIOGRAPH - ROB2003002
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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: JDI
Device Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
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: 888.3350
Third Party Flag: N
Medical Specialty: OR
Code: LZO
Device Name: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
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: 888.3353
Third Party Flag: N
Medical Specialty: OR
Code: MBL
Device Name: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
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: 888.3358
Third Party Flag: N
Medical Specialty: OR
Code: MEH
Device Name: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
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: 888.3353
Third Party Flag: N
Medical Specialty: OR
Code: LWJ
Device Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
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: 888.3360
Third Party Flag: N
Medical Specialty: OR
Code: LPH
Device Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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: 888.3358
Third Party Flag: N
Medical Specialty: OR
Code: KWZ
Device Name: Prosthesis, Hip, Constrained, Cemented Or Uncemented, 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: 888.3310
Third Party Flag: N
Medical Specialty: OR
Device IdentifiersDevice Id: 00885556921524
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
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