116230

GUDID 00848486002978

CHECKPOINT 3.5MM HEX X 15MM

MAKO SURGICAL CORP.

Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable

• Primary Device ID: 00848486002978
• NIH Device Record Key: 85b76740-833e-42af-b1f1-728fbd02557f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 116230
• Catalog Number: 116230
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0
• Length: 15 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848486002978 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121064

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

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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• 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