INSTRUMENT 700002112890

GUDID 07613327625868

Spine Pedicle End Effector

MAKO SURGICAL CORP.

Robotic surgical navigation system

• Primary Device ID: 07613327625868
• NIH Device Record Key: 3654d5c1-6908-4093-bdf3-200413e93c75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INSTRUMENT
• Version Model Number: 700002112890
• Catalog Number: 700002112890
• 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	07613327625868 [Primary]

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[07613327625868]

Moist Heat or Steam Sterilization

[07613327625868]

Moist Heat or Steam Sterilization

[07613327625868]

Moist Heat or Steam Sterilization

[07613327625868]

Moist Heat or Steam Sterilization

[07613327625868]

Moist Heat or Steam Sterilization

[07613327625868]

Moist Heat or Steam Sterilization

[07613327625868]

Moist Heat or Steam Sterilization

[07613327625868]

Moist Heat or Steam Sterilization

[07613327625868]

Moist Heat or Steam Sterilization

[07613327625868]

Moist Heat or Steam Sterilization

[07613327625868]

Moist Heat or Steam Sterilization

[07613327625868]

Moist Heat or Steam Sterilization

[07613327625868]

Moist Heat or Steam Sterilization

[07613327625868]

Moist Heat or Steam Sterilization

[07613327625868]

Moist Heat or Steam Sterilization

[07613327625868]

Moist Heat or Steam Sterilization

[07613327625868]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-14
• Device Publish Date: 2024-10-04

On-Brand Devices [INSTRUMENT]

• 07613327625875: Spine Pedicle Registration Tool
• 07613327625868: Spine Pedicle End Effector