ACCOLADE II 210433-2735

GUDID 00848486028060

127¿ 35mm NECK TRIAL

MAKO SURGICAL CORP.

Femoral stem prosthesis trial

• Primary Device ID: 00848486028060
• NIH Device Record Key: f59748f2-54e6-4d94-b03c-0c06627ab17d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCOLADE II
• Version Model Number: 210433-2735
• Catalog Number: 210433-2735
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848486028060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141989

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[00848486028060]

Moist Heat or Steam Sterilization

[00848486028060]

Moist Heat or Steam Sterilization

[00848486028060]

Moist Heat or Steam Sterilization

[00848486028060]

Moist Heat or Steam Sterilization

[00848486028060]

Moist Heat or Steam Sterilization

[00848486028060]

Moist Heat or Steam Sterilization

[00848486028060]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-24

On-Brand Devices [ACCOLADE II]

• 00848486028138: 132¿ 40mm NECK TRIAL
• 00848486028121: 132¿ 37mm NECK TRIAL
• 00848486028114: 132¿ 35mm NECK TRIAL
• 00848486028107: 132¿ 30mm NECK TRIAL
• 00848486028091: 132¿ 27mm NECK TRIAL
• 00848486028084: 127¿ 40mm NECK TRIAL
• 00848486028077: 127¿ 37mm NECK TRIAL
• 00848486028060: 127¿ 35mm NECK TRIAL
• 00848486028053: 127¿ 30mm NECK TRIAL
• 00848486028046: 127¿ 27mm NECK TRIAL