V40 110755

GUDID 00848486017187

POSTERO-LATERAL BROACH ARRAY

MAKO SURGICAL CORP.

Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor Patient positioning sensor

• Primary Device ID: 00848486017187
• NIH Device Record Key: 8c01ff2c-d5ff-4c4f-8d38-d4345b2788ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V40
• Version Model Number: 110755
• Catalog Number: 110755
• 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	00848486017187 [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

[00848486017187]

Moist Heat or Steam Sterilization

[00848486017187]

Moist Heat or Steam Sterilization

[00848486017187]

Moist Heat or Steam Sterilization

[00848486017187]

Moist Heat or Steam Sterilization

[00848486017187]

Moist Heat or Steam Sterilization

[00848486017187]

Moist Heat or Steam Sterilization

[00848486017187]

Moist Heat or Steam Sterilization

[00848486017187]

Moist Heat or Steam Sterilization

[00848486017187]

Moist Heat or Steam Sterilization

[00848486017187]

Moist Heat or Steam Sterilization

[00848486017187]

Moist Heat or Steam Sterilization

[00848486017187]

Moist Heat or Steam Sterilization

[00848486017187]

Moist Heat or Steam Sterilization

[00848486017187]

Moist Heat or Steam Sterilization

[00848486017187]

Moist Heat or Steam Sterilization

[00848486017187]

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

On-Brand Devices [V40]

• 00848486017194: ANTERO-LATERAL BROACH ARRAY
• 00848486017187: POSTERO-LATERAL BROACH ARRAY