111870

GUDID 00848486002886

PELVIC O-CLAMP

MAKO SURGICAL CORP.

Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning 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.

• 07613327599985 - Mako: 2023-07-31
• 07613327600001 - Mako: 2023-07-31
• 07613327600063 - Mako: 2023-07-31
• 07613327600070 - Mako: 2023-07-31
• 07613327601008 - Mako: 2023-07-31
• 00848486022747 - Calibration End Effector Inverted: 2022-10-13 Calibration End Effector Inverted
• 07613327395341 - Mako: 2021-04-07
• 07613327395280 - NA: 2020-12-23