111870

GUDID 00848486002886

PELVIC O-CLAMP

MAKO SURGICAL CORP.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00848486002886
• NIH Device Record Key: b1c362ff-4130-41fb-a0b1-606f177f611e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 111870
• Catalog Number: 111870
• 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	00848486002886 [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

[00848486002886]

Moist Heat or Steam Sterilization

[00848486002886]

Moist Heat or Steam Sterilization

[00848486002886]

Moist Heat or Steam Sterilization

[00848486002886]

Moist Heat or Steam Sterilization

[00848486002886]

Moist Heat or Steam Sterilization

[00848486002886]

Moist Heat or Steam Sterilization

[00848486002886]

Moist Heat or Steam Sterilization

[00848486002886]

Moist Heat or Steam Sterilization

[00848486002886]

Moist Heat or Steam Sterilization

[00848486002886]

Moist Heat or Steam Sterilization

[00848486002886]

Moist Heat or Steam Sterilization

[00848486002886]

Moist Heat or Steam Sterilization

[00848486002886]

Moist Heat or Steam Sterilization

[00848486002886]

Moist Heat or Steam Sterilization

[00848486002886]

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

Devices Manufactured by MAKO SURGICAL CORP.

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• 07613327627572 - Mako: 2024-11-26 Blade-Narrow
• 07613327626971 - Mako: 2024-11-25 Mako Shoulder Array Kit
• 07613327627213 - Mako: 2024-11-25 Mako Shoulder Burr
• 07613327625868 - INSTRUMENT: 2024-10-14 Spine Pedicle End Effector
• 07613327625875 - INSTRUMENT: 2024-10-14 Spine Pedicle Registration Tool
• 07613327624304 - NA: 2024-09-26 Robotic Arm