OrthoView

GUDID B021712WEBWK0

OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded into it. This enables the surgeon to gather measurements

MERIDIAN TECHNIQUE LIMITED

Orthopaedic/craniofacial implantation planning software

• Primary Device ID: B021712WEBWK0
• NIH Device Record Key: a040e508-f779-4bd7-82d9-bd475156f325
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoView
• Version Model Number: 7.1.2
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B021712WEBWK0 [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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-01-08
• Device Publish Date: 2017-11-02

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