205020

GUDID 00848486007065

Parallel Hip End Effector

MAKO SURGICAL CORP.

Drilling power tool attachment, basic

• Primary Device ID: 00848486007065
• NIH Device Record Key: f522a218-3da7-46d8-b372-a3beb1f96988
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 205020
• Catalog Number: 205020
• 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: true
• 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	00848486007065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112507
• Premarket Notification: K121064

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

Moist Heat or Steam Sterilization

[00848486007065]

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

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• 07613327523874 - Mako: 2025-02-14 MICS Sagittal Saw Attachment , Angled
• 07613327627220 - Mako: 2024-11-26 MAKO SHOULDER ROUTER
• 07613327627565 - Mako: 2024-11-26 MICS SAGITTAL BLADE, STANDARD
• 07613327627572 - Mako: 2024-11-26 Blade-Narrow
• 07613327626971 - Mako: 2024-11-25 Mako Shoulder Array Kit