SMR TT Augmented 360 1375.15.569

GUDID 08033390180047

SMR TT Augmented 360 Baseplate S-R 19°X

LIMACORPORATE SPA

Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated Shoulder glenoid fossa prosthesis, prefabricated

• Primary Device ID: 08033390180047
• NIH Device Record Key: 9522df10-e04d-4ea3-a8ee-aeee508ecd99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMR TT Augmented 360
• Version Model Number: 1375.15.569
• Catalog Number: 1375.15.569
• Company DUNS: 432066322
• Company Name: LIMACORPORATE SPA
• 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 Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390180047 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200171

FDA Product Code

• PHX: Shoulder Prosthesis, Reverse Configuration

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-07
• Device Publish Date: 2020-11-27

On-Brand Devices [SMR TT Augmented 360]

• 08033390162104: SMR TT Augmented 360 Baseplate S-R +4mm, Dia. 27 mm
• 08033390161848: SMR TT Augmented 360 Baseplate S-R +2mm, Dia. 27 mm
• 08033390161473: SMR TT Augmented 360 Baseplate S-R 15°, Dia. 27 mm
• 08033390161466: SMR TT Augmented 360 Baseplate S-R 10°, Dia. 27 mm
• 08033390161459: SMR TT Augmented 360 Baseplate S-R 7°, Dia. 27 mm
• 08033390180337: SMR TT Augmented 360 Baseplate S-R 15°X
• 08033390180320: SMR TT Augmented 360 Baseplate S-R 10°X
• 08033390180313: SMR TT Augmented 360 Baseplate S-R 7°X
• 08033390180047: SMR TT Augmented 360 Baseplate S-R 19°X
• 08033390161503: SMR TT Augmented 360 Baseplate S-R 19°