RIO 160230

GUDID 00848486020385

REGISTRATION ARRAY

MAKO SURGICAL CORP.

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