207110

GUDID 00848486022211

Guidance Module

MAKO SURGICAL CORP.

Robotic surgical navigation system

• Primary Device ID: 00848486022211
• NIH Device Record Key: 1556fb1d-206f-454d-aa87-a82f6ee3e233
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 207110
• Catalog Number: 207110
• 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: true
• 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	00848486022211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112507

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

[00848486022211]

Moist Heat or Steam Sterilization

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.

• 07613327595482 - Scapular Clamp: 2026-02-09
• 07613327595567 - Robotic Arm Array Mount: 2026-02-09
• 07613327595772 - Shoulder irrigation Clip, Sterile: 2026-02-09
• 07613327623277 - Lower Tray, Mako Shoulder Tray: 2026-02-09
• 07613327623284 - Double Tier Tray Outer Shell: 2026-02-09
• 07613327625530 - MAKO Knee Tray Bottom Insert: 2026-02-09
• 07613327522006 - Mako: 2026-01-22 MICS 3 Handpiece
• 07613327595505 - Mako Glenoid Retractor: 2026-01-16