RESTORIS Z, RIO 206392

GUDID 00848486029432

SHELL IMPACTOR, STRAIGHT

MAKO SURGICAL CORP.

Orthopaedic implant impactor

• Primary Device ID: 00848486029432
• NIH Device Record Key: b8874c94-463d-4561-9d2d-28ad35232fa3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESTORIS Z, RIO
• Version Model Number: 206392
• Catalog Number: 206392
• 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	00848486029432 [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

[00848486029432]

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 [RESTORIS Z, RIO]

• 00848486029449: SHELL IMPACTOR, OFFSET
• 00848486029432: SHELL IMPACTOR, STRAIGHT