160278

GUDID 00848486020576

ACETABULAR REAMER ¿ 59mm

MAKO SURGICAL CORP.

Acetabular orthopaedic reamer

• Primary Device ID: 00848486020576
• NIH Device Record Key: 2f99421a-7c85-43d4-b544-f90d850f3d57
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 160278
• Catalog Number: 160278
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00848486020576 [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.

• 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