219999

GUDID 07613327395280

MAKO SURGICAL CORP.

Robotic surgical navigation system

• Primary Device ID: 07613327395280
• NIH Device Record Key: b2759118-9dbf-48ec-967b-e1c1e1c807e7
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 219999
• Catalog Number: 219999
• Company DUNS: 175239677
• Company Name: MAKO SURGICAL CORP.
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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
GS1	07613327395280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170593

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

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: 2020-12-23
• Device Publish Date: 2020-12-15

Devices Manufactured by MAKO SURGICAL CORP.

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• 07613327627213 - Mako: 2024-11-25 Mako Shoulder Burr
• 07613327625868 - INSTRUMENT: 2024-10-14 Spine Pedicle End Effector
• 07613327625875 - INSTRUMENT: 2024-10-14 Spine Pedicle Registration Tool