RIO 160230

GUDID 00848486020385

REGISTRATION ARRAY

MAKO SURGICAL CORP.

Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor

• Primary Device ID: 00848486020385
• NIH Device Record Key: 4b5156fd-0c7c-4e77-854a-2a855a96c294
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIO
• Version Model Number: 160230
• Catalog Number: 160230
• 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	00848486020385 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121064

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[00848486020385]

Moist Heat or Steam Sterilization

[00848486020385]

Moist Heat or Steam Sterilization

[00848486020385]

Moist Heat or Steam Sterilization

[00848486020385]

Moist Heat or Steam Sterilization

[00848486020385]

Moist Heat or Steam Sterilization

[00848486020385]

Moist Heat or Steam Sterilization

[00848486020385]

Moist Heat or Steam Sterilization

[00848486020385]

Moist Heat or Steam Sterilization

[00848486020385]

Moist Heat or Steam Sterilization

[00848486020385]

Moist Heat or Steam Sterilization

[00848486020385]

Moist Heat or Steam Sterilization

[00848486020385]

Moist Heat or Steam Sterilization

[00848486020385]

Moist Heat or Steam Sterilization

[00848486020385]

Moist Heat or Steam Sterilization

[00848486020385]

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

On-Brand Devices [RIO]

• 00848486021702: LAPTOP COMPUTER
• 00848486020385: REGISTRATION ARRAY
• 00848486017446: BASE ARRAY
• 00848486017026: System Irrigation Tube
• 00848486016319: System Irrigation Clip
• 00848486015879: RIO¿ Foot Switch
• 00848486002916: SYSTEM QUICK CONNECT BASE ARRAY
• 00848486002893: KNEE APPLICATION DUAL PIN ARRAY CLAMP
• 00848486002770: KNEE APPLICATION DUAL PIN BASE CLAMP