Mazor X Spine Disposable Kit

GUDID 07290115750881

MAZOR ROBOTICS LTD

Orthopaedic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 07290115750881
• NIH Device Record Key: 7d2f97b4-b3c8-45b8-a1d3-d08bff18c9d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mazor X Spine Disposable Kit
• Version Model Number: KIT0574-08
• Company DUNS: 532681590
• Company Name: MAZOR ROBOTICS LTD
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• 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
GS1	07290115750881 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203005

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-26
• Device Publish Date: 2021-08-18

On-Brand Devices [Mazor X Spine Disposable Kit]

• 07290109183268: KIT0574-06
• 07290109181110: Mazor X Spine Disposable Kit
• 07290109181011: Mazor X Spine Disposable Kit
• 07290109184494: KIT0574-07
• 07290115750881: KIT0574-08
• 07290115752786: KIT0574-10
• 07290115753141: KIT0574-11