111650

GUDID 00848486001346

CHECKPOINT KIT

MAKO SURGICAL CORP.

Imaging lesion localization marker, implantable

• Primary Device ID: 00848486001346
• NIH Device Record Key: 3087669d-452a-4b52-b5f3-f7ff54bffa10
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 111650
• Catalog Number: 111650
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00848486001346 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112507

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by MAKO SURGICAL CORP.

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• 07613327626971 - Mako: 2024-11-25 Mako Shoulder Array Kit
• 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
• 07613327624304 - NA: 2024-09-26 Robotic Arm