Mako 180735-1

GUDID 00848486016548

Tibial Bearing Insert

MAKO SURGICAL CORP.

Unicondylar knee prosthesis

• Primary Device ID: 00848486016548
• NIH Device Record Key: 7044932b-3536-4b20-b9f4-2393d5dad271
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mako
• Version Model Number: 180735-1
• Catalog Number: 180735-1
• 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: 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 Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848486016548 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150307

FDA Product Code

• NJD: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, UNCEMENTED, POROUS-COATED, METAL/POLYMER

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: 2015-11-04

On-Brand Devices [Mako]

• 00848486031992: Blade - Narrow
• 00848486030957: MAKO STRAIGHT REAMER HANDLE
• 00848486029715: CASE HIP INSTRUMENT KIT
• 00848486029555: Blade - Standard
• 00848486016876: Ball Burr
• 00848486016869: Integrated Cutting System Sagittal Blade - Narrow
• 00848486016852: Integrated Cutting System Sagittal Blade - Standard
• 00848486016739: Tibial Bearing Insert
• 00848486016715: Tibial Bearing Insert
• 00848486016708: Tibial Bearing Insert
• 00848486016692: Tibial Bearing Insert
• 00848486016685: Tibial Bearing Insert
• 00848486016661: Tibial Bearing Insert
• 00848486016654: Tibial Bearing Insert
• 00848486016647: Tibial Bearing Insert
• 00848486016630: Tibial Bearing Insert
• 00848486016616: Tibial Bearing Insert
• 00848486016609: Tibial Bearing Insert
• 00848486016593: Tibial Bearing Insert
• 00848486016586: Tibial Bearing Insert
• 00848486016562: Tibial Bearing Insert
• 00848486016555: Tibial Bearing Insert
• 00848486016548: Tibial Bearing Insert
• 00848486016531: Tibial Bearing Insert
• 00848486016517: Tibial Bearing Insert
• 00848486016500: Tibial Bearing Insert
• 00848486016494: Tibial Bearing Insert
• 00848486016487: Tibial Bearing Insert
• 00848486016463: Tibial Bearing Insert
• 00848486016456: Tibial Bearing Insert
• 00848486016449: Tibial Bearing Insert
• 00848486016432: Tibial Bearing Insert
• 00848486016418: Tibial Bearing Insert
• 00848486016401: Tibial Bearing Insert
• 00848486016395: Tibial Bearing Insert
• 00848486016388: Tibial Bearing Insert
• 00848486016364: Tibial Bearing Insert
• 00848486016357: Tibial Bearing Insert
• 00848486016340: Tibial Bearing Insert
• 07613327386479: MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 9 MM
• 07613327386455: MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 10 MM
• 07613327386448: MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 12 MM
• 07613327386431: MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 9 MM
• 07613327386417: MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 4 - 10 MM
• 07613327386356: MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 8 - 8 MM
• 07613327386325: MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 8 - 10 MM
• 07613327386301: MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 8 - 12 MM
• 07613327386271: MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 8 - 9 MM
• 07613327386226: MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 7 - 8 MM
• 07613327386219: MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 7 - 12 MM