PRIMA TT Glenoid 1975.14.865

GUDID 08033390244930

PRIMA TT Glenoid - Modular Reverse TT Baseplate Dia. 28 mm; Full Wedge 15°X

LIMACORPORATE SPA

Shoulder glenoid fossa prosthesis, prefabricated

• Primary Device ID: 08033390244930
• NIH Device Record Key: 4fd13bc6-e6e6-4700-a37a-c983eb0e8e29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRIMA TT Glenoid
• Version Model Number: 1975.14.865
• Catalog Number: 1975.14.865
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390244930 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222427

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: 2022-12-12
• Device Publish Date: 2022-12-03

On-Brand Devices [PRIMA TT Glenoid]

• 08033390244961: PRIMA TT Glenoid - Eccentrical Glenosphere Dia. 40 mm; ECC.4 mm
• 08033390244954: PRIMA TT Glenoid - Eccentrical Glenosphere Dia. 36 mm; ECC.4 mm
• 08033390244947: PRIMA TT Glenoid - Modular Reverse TT Baseplate Dia. 28 mm; Full Wedge 20°X
• 08033390244930: PRIMA TT Glenoid - Modular Reverse TT Baseplate Dia. 28 mm; Full Wedge 15°X
• 08033390244923: PRIMA TT Glenoid - Modular Reverse TT Baseplate Dia. 28 mm; Full Wedge 20°
• 08033390244916: PRIMA TT Glenoid - Modular Reverse TT Baseplate Dia. 28 mm; Full Wedge 15°
• 08033390244909: PRIMA TT Glenoid - Modular Reverse TT Baseplate Dia. 28 mm; Full Wedge 10°
• 08033390244893: PRIMA TT Glenoid - Modular Reverse TT Baseplate Dia. 28 mm; Regular
• 08033390244886: PRIMA TT Glenoid - Glenoid TT Peg X-LONG; Dia. 11 mm; L. 30 mm; Full TT
• 08033390244879: PRIMA TT Glenoid - Glenoid TT Peg LONG; Dia. 11 mm; L. 25 mm; Full TT
• 08033390244862: PRIMA TT Glenoid - Glenoid TT Peg LONG; Dia. 11 mm; L. 25 mm
• 08033390244855: PRIMA TT Glenoid - Glenoid TT Peg MEDIUM; Dia. 11 mm; L. 17 mm
• 08033390244848: PRIMA TT Glenoid - Modular Reverse TT Baseplate Dia. 25 mm; Full Wedge 15°
• 08033390244831: PRIMA TT Glenoid - Modular Reverse TT Baseplate Dia. 25 mm; Regular
• 08033390244824: PRIMA TT Glenoid - Monoblock Reverse TT Baseplate Dia. 25 mm; Regular
• 08033390244688: PRIMA TT Glenoid - Screw for Glenosphere High Lateralization (9mm)
• 08033390244671: PRIMA TT Glenoid - Glenosphere Connector with Screw High Lateralization (9mm)
• 08033390244657: PRIMA TT Glenoid - Glenosphere Dia. 36 mm
• 08033390242943: PRIMA TT Glenoid - Peripheral Screw Cortical; Dia. 5 mm; L. 50 mm
• 08033390242936: PRIMA TT Glenoid - Peripheral Screw Cortical; Dia. 5 mm; L. 46 mm
• 08033390242929: PRIMA TT Glenoid - Peripheral Screw Cortical; Dia. 5 mm; L. 42 mm
• 08033390242905: PRIMA TT Glenoid - Peripheral Screw Cortical; Dia. 5 mm; L. 38 mm
• 08033390242899: PRIMA TT Glenoid - Peripheral Screw Cortical; Dia. 5 mm; L. 34 mm
• 08033390242882: PRIMA TT Glenoid - Peripheral Screw Cortical; Dia. 5 mm; L. 30 mm
• 08033390242875: PRIMA TT Glenoid - Peripheral Screw Cortical; Dia. 5 mm; L. 24 mm
• 08033390242868: PRIMA TT Glenoid - Peripheral Screw Cortical; Dia. 5 mm; L. 22 mm
• 08033390242851: PRIMA TT Glenoid - Peripheral Screw Cortical; Dia. 5 mm; L. 20 mm
• 08033390242844: PRIMA TT Glenoid - Central Compressive Screw Cancellous; Dia. 6,5 mm; L. 50 mm
• 08033390242837: PRIMA TT Glenoid - Central Compressive Screw Cancellous; Dia. 6,5 mm; L. 45 mm
• 08033390242820: PRIMA TT Glenoid - Central Compressive Screw Cancellous; Dia. 6,5 mm; L. 40 mm
• 08033390242813: PRIMA TT Glenoid - Central Compressive Screw Cancellous; Dia. 6,5 mm; L. 35 mm
• 08033390242806: PRIMA TT Glenoid - Central Compressive Screw Cancellous; Dia. 6,5 mm; L. 30 mm
• 08033390242790: PRIMA TT Glenoid - Central Compressive Screw Cortical; Dia. 5 mm; L. 50 mm
• 08033390242783: PRIMA TT Glenoid - Central Compressive Screw Cortical; Dia. 5 mm; L. 45 mm
• 08033390242776: PRIMA TT Glenoid - Central Compressive Screw Cortical; Dia. 5 mm; L. 40 mm
• 08033390242769: PRIMA TT Glenoid - Central Compressive Screw Cortical; Dia. 5 mm; L. 35 mm
• 08033390242752: PRIMA TT Glenoid - Central Compressive Screw Cortical; Dia. 5 mm; L. 30 mm
• 08033390241212: PRIMA TT Glenoid - Positioning Rod for Trial Glenosphere
• 08033390241151: PRIMA TT Glenoid - Retentive Screwdriver 3mm Hex - Zimmer Connection
• 08033390241144: PRIMA TT Glenoid - Screwdriver T20 - Zimmer Connection
• 08033390241137: PRIMA TT Glenoid - Handle Zimmer Connection
• 08033390241120: PRIMA TT Glenoid - T-Handle Zimmer Connection
• 08033390241106: PRIMA TT Glenoid - Guide for Peripheral Drilling
• 08033390241090: PRIMA TT Glenoid - Baseplate Impactor
• 08033390241083: PRIMA TT Glenoid - Connector Extractor
• 08033390241076: PRIMA TT Glenoid - Rod for Glenosphere Extraction
• 08033390241069: PRIMA TT Glenoid - Glenosphere/Baseplate Extractor
• 08033390241052: PRIMA TT Glenoid - Trial Glenosphere Dia. 42 mm ECC.
• 08033390241045: PRIMA TT Glenoid - Trial Glenosphere Dia. 40 mm ECC.
• 08033390241038: PRIMA TT Glenoid - Trial Glenosphere Dia. 36 mm ECC.