RESTORIS ESYNTIAL 180743-9

GUDID 00848486015411

MCK Onlay Tibial Insert

MAKO SURGICAL CORP.

Unicondylar knee prosthesis

• Primary Device ID: 00848486015411
• NIH Device Record Key: a436e0f9-3591-421d-815b-696ad474d0be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESTORIS ESYNTIAL
• Version Model Number: 180743-9
• Catalog Number: 180743-9
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848486015411 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133039

FDA Product Code

• HSX: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, 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: 2015-09-24

On-Brand Devices [RESTORIS ESYNTIAL]

• 00848486015862: MCK Onlay Tibial Insert
• 00848486015855: MCK Onlay Tibial Insert
• 00848486015848: MCK Onlay Tibial Insert
• 00848486015831: MCK Onlay Tibial Insert
• 00848486015824: MCK Onlay Tibial Insert
• 00848486015817: MCK Onlay Tibial Insert
• 00848486015800: MCK Onlay Tibial Insert
• 00848486015794: MCK Onlay Tibial Insert
• 00848486015787: MCK Onlay Tibial Insert
• 00848486015770: MCK Onlay Tibial Insert
• 00848486015763: MCK Onlay Tibial Insert
• 00848486015756: MCK Onlay Tibial Insert
• 00848486015749: MCK Onlay Tibial Insert
• 00848486015732: MCK Onlay Tibial Insert
• 00848486015725: MCK Onlay Tibial Insert
• 00848486015718: MCK Onlay Tibial Insert
• 00848486015701: MCK Onlay Tibial Insert
• 00848486015695: MCK Onlay Tibial Insert
• 00848486015688: MCK Onlay Tibial Insert
• 00848486015671: MCK Onlay Tibial Insert
• 00848486015664: MCK Onlay Tibial Insert
• 00848486015657: MCK Onlay Tibial Insert
• 00848486015640: MCK Onlay Tibial Insert
• 00848486015633: MCK Onlay Tibial Insert
• 00848486015626: MCK Onlay Tibial Insert
• 00848486015619: MCK Onlay Tibial Insert
• 00848486015602: MCK Onlay Tibial Insert
• 00848486015596: MCK Onlay Tibial Insert
• 00848486015589: MCK Onlay Tibial Insert
• 00848486015572: MCK Onlay Tibial Insert
• 00848486015565: MCK Onlay Tibial Insert
• 00848486015558: MCK Onlay Tibial Insert
• 00848486015541: MCK Onlay Tibial Insert
• 00848486015534: MCK Onlay Tibial Insert
• 00848486015527: MCK Onlay Tibial Insert
• 00848486015510: MCK Onlay Tibial Insert
• 00848486015503: MCK Onlay Tibial Insert
• 00848486015497: MCK Onlay Tibial Insert
• 00848486015480: MCK Onlay Tibial Insert
• 00848486015473: MCK Onlay Tibial Insert
• 00848486015466: MCK Onlay Tibial Insert
• 00848486015459: MCK Onlay Tibial Insert
• 00848486015442: MCK Onlay Tibial Insert
• 00848486015435: MCK Onlay Tibial Insert
• 00848486015428: MCK Onlay Tibial Insert
• 00848486015411: MCK Onlay Tibial Insert
• 00848486015404: MCK Onlay Tibial Insert
• 00848486015398: MCK Onlay Tibial Insert
• 00848486015381: MCK Onlay Tibial Insert
• 00848486015374: MCK Onlay Tibial Insert