229999

GUDID 07613327624304

Robotic Arm

MAKO SURGICAL CORP.

Robotic surgical navigation system

• Primary Device ID: 07613327624304
• NIH Device Record Key: de2198f6-8021-4bb9-9139-2205701b1902
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 229999
• Catalog Number: 229999
• 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	07613327624304 [Primary]

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: 2024-09-26
• Device Publish Date: 2024-09-18

Devices Manufactured by MAKO SURGICAL CORP.

• 07613327522006 - Mako: 2026-01-22 MICS 3 Handpiece
• 07613327595505 - Mako Glenoid Retractor: 2026-01-16
• 07613327595741 - Black Probe: 2026-01-16
• 07613327523874 - Mako: 2025-02-14 MICS Sagittal Saw Attachment , Angled
• 07613327627220 - Mako: 2024-11-26 MAKO SHOULDER ROUTER
• 07613327627565 - Mako: 2024-11-26 MICS SAGITTAL BLADE, STANDARD
• 07613327627572 - Mako: 2024-11-26 Blade-Narrow
• 07613327626971 - Mako: 2024-11-25 Mako Shoulder Array Kit