VELYS Hip Navigation 451580051

GUDID 10603295522850

VELYS Hip Navigation for Windows

DEPUY ORTHOPAEDICS, INC.

Orthopaedic stereotactic surgery system

• Primary Device ID: 10603295522850
• NIH Device Record Key: f660ff35-5c09-421a-b410-9c192f5ad823
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VELYS Hip Navigation
• Version Model Number: 451580051
• Catalog Number: 451580051
• Company DUNS: 080506581
• Company Name: DEPUY ORTHOPAEDICS, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295522850 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160284

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: 2021-08-09
• Device Publish Date: 2021-07-30

On-Brand Devices [VELYS Hip Navigation]

• 10603295532040: VELYS Hip Navigation for iOS
• 10603295522850: VELYS Hip Navigation for Windows