Shoulder 1.5 Installation Disk 700004378746

GUDID 07613327683653

MAKO SURGICAL CORP.

Robotic surgical navigation system application software

• Primary Device ID: 07613327683653
• NIH Device Record Key: 026b27eb-ca8d-4012-a4f0-5d8b529010c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shoulder 1.5 Installation Disk
• Version Model Number: 700004378746
• Catalog Number: 700004378746
• 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: false
• 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	07613327683653 [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: 2026-03-11
• Device Publish Date: 2026-03-03

Devices Manufactured by MAKO SURGICAL CORP.

• 07613327627725 - Mako: 2026-03-18
• 07613327683653 - Shoulder 1.5 Installation Disk: 2026-03-11
• 07613327683653 - Shoulder 1.5 Installation Disk: 2026-03-11
• 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