SMR TT Augmented 360 1375.15.507

GUDID 08033390161459

SMR TT Augmented 360 Baseplate S-R 7°, Dia. 27 mm

LIMACORPORATE SPA

Shoulder glenoid fossa prosthesis, prefabricated

• Primary Device ID: 08033390161459
• NIH Device Record Key: 992f906a-541b-4909-bf7b-d339cb82d503
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMR TT Augmented 360
• Version Model Number: 1375.15.507
• Catalog Number: 1375.15.507
• 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 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	08033390161459 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191746

FDA Product Code

• PHX: Shoulder Prosthesis, Reverse Configuration

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-23
• Device Publish Date: 2019-11-28

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°