ANATO 209873

GUDID 00848486030322

NEUTRAL TRIAL NECK, ANTEVERTED

MAKO SURGICAL CORP.

Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial Femoral stem prosthesis trial

• Primary Device ID: 00848486030322
• NIH Device Record Key: 14bfd38d-b70f-4862-b871-202f86453c83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANATO
• Version Model Number: 209873
• Catalog Number: 209873
• 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	00848486030322 [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

[00848486030322]

Moist Heat or Steam Sterilization

[00848486030322]

Moist Heat or Steam Sterilization

[00848486030322]

Moist Heat or Steam Sterilization

[00848486030322]

Moist Heat or Steam Sterilization

[00848486030322]

Moist Heat or Steam Sterilization

[00848486030322]

Moist Heat or Steam Sterilization

[00848486030322]

Moist Heat or Steam Sterilization

[00848486030322]

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 [ANATO]

• 00848486030322: NEUTRAL TRIAL NECK, ANTEVERTED
• 00848486030315: NEUTRAL TRIAL NECK, RIGHT
• 00848486030308: NEUTRAL TRIAL NECK, LEFT