SMR TT Hybrid Glenoid 1379.59.200

GUDID 08033390121651

TT Hybrid Glenoid Baseplate Std LOW - Peg S

LIMACORPORATE SPA

Shoulder glenoid fossa prosthesis, prefabricated

• Primary Device ID: 08033390121651
• NIH Device Record Key: e5cec7cb-55a8-4140-acec-1a7b7fa1389d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMR TT Hybrid Glenoid
• Version Model Number: 1379.59.200
• Catalog Number: 1379.59.200
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08033390121651 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163397

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: 5
• Public Version Date: 2019-12-23
• Device Publish Date: 2017-07-05

On-Brand Devices [SMR TT Hybrid Glenoid]

• 08033390122016: TT Hybrid Glenoid Baseplate Large +2 - Peg L
• 08033390121996: TT Hybrid Glenoid Baseplate Large - Peg L
• 08033390121965: TT HybHybrid Glenoid Baseplate Large +2 - Peg S
• 08033390121941: TT Hybrid Glenoid Baseplate Large - Peg S
• 08033390121934: TT Hybrid Glenoid Baseplate Large LOW +2 - Peg L
• 08033390121903: TT Hybrid Glenoid Baseplate Large LOW +2 - Peg S
• 08033390121866: TT Hybrid Glenoid Baseplate Std +2 - Peg L
• 08033390121842: TT Hybrid Glenoid Baseplate Std - Peg L
• 08033390121811: TT Hybrid Glenoid Baseplate Std +2 - Peg S
• 08033390121798: TT Hybrid Glenoid Baseplate Std - Peg S
• 08033390121729: TT Hybrid Glenoid Baseplate Std LOW +2 - Peg L
• 08033390121705: TT Hybrid Glenoid Baseplate Std LOW - Peg L
• 08033390121675: TT Hybrid Glenoid Baseplate Std LOW +2 - Peg S
• 08033390121651: TT Hybrid Glenoid Baseplate Std LOW - Peg S
• 08033390121620: TT Hybrid Glenoid Baseplate Small +2 - Peg L
• 08033390121606: TT Hybrid Glenoid Baseplate Small - Peg L
• 08033390121576: TT Hybrid Glenoid Baseplate Small +2 - Peg S
• 08033390121552: TT Hybrid Glenoid Baseplate Small - Peg S
• 08033390121538: TT Hybrid Glenoid Baseplate Small LOW +2 - Peg L
• 08033390121491: TT Hybrid Glenoid Baseplate Small LOW +2 - Peg S
• 08033390121118: TT Hybrid Reverse Baseplate+Screw Std
• 08033390121002: TT Hybrid Glenoid Baseplate Small LOW - Peg S
• 08033390115728: TT Hybrid Reverse Baseplate+Screw Small
• 08033390115704: TT Hybrid Glenoid Baseplate Large LOW - Peg L
• 08033390115681: TT Hybrid Glenoid Baseplate Large LOW - Peg S
• 08033390115674: TT Hybrid Glenoid Baseplate Small LOW - Peg L