OrthoView

GUDID B02175WEBWK0

OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded into it. This enables the surgeon to gather measurements and angles of anatomical landmarks, visualize the effect of the surgery by animating regions of the image, size and position templates representing prosthetic or fixation devices and output reports specifying the measurements and device decisions.

MERIDIAN TECHNIQUE LIMITED

Orthopaedic/craniofacial implantation planning software

• Primary Device ID: B02175WEBWK0
• NIH Device Record Key: 32741b7f-67c4-418a-bf7b-6cfe7aacffb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoView
• Version Model Number: 7.5
• Company DUNS: 640829818
• Company Name: MERIDIAN TECHNIQUE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B02175WEBWK0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063327

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-25
• Device Publish Date: 2022-11-17

On-Brand Devices [OrthoView]

• B02173MACWK0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021711WINWK0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021711WEBWK0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B02173WEBIPX0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B02173WINWK70: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B02173WINWK0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B02173WINDM7: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B02173WEBWK0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021731WINWK0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021731WINISD0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B02171WINWK70: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021715WINIDC0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021715WEBWK0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021714WINWK0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021714WINDM70: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021714WEBWK0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021714WEBMW0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021713WINWK0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021713WEBWK0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021712WINWK70: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021712WINWK0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021712WEBWK0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021712WEBELO0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021706WEBWK0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021705WEBIPX0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021704WINISD0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021703WINRSH0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021703WINELO0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021702WINWK70: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021702WINWK0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021702WININD0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021702WINIDC0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021702WINIAR0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021702WEBWK0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021732WINIDC0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021732WEBWK0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021732WEBIDC0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B02174WEBWK0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021741WEBWK0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021733WINAN0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021744WEBWK0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021734WININD0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021746WEBWK0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021747WEBWK0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B02175WINWK0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B02175WEBWK0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B02175WINIAR0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B0217502WEBWK0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021751WINWK0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in
• B021751WEBWK0: OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded in