H-Max Hip 9042.05.080

GUDID 08033390062824

Broach #8

LIMACORPORATE SPA

Orthopaedic broach

• Primary Device ID: 08033390062824
• NIH Device Record Key: 228db51e-0d9c-4026-a024-d675ec3cd5bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: H-Max Hip
• Version Model Number: Broach
• Catalog Number: 9042.05.080
• Company DUNS: 432066322
• Company Name: LIMACORPORATE SPA
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	08033390062824 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112091

FDA Product Code

• JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Sterilization

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

[08033390062824]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-05
• Device Publish Date: 2016-05-12

Devices Manufactured by LIMACORPORATE SPA

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• 08033390275651 - PRIMA TT Glenoid: 2024-04-12 Prima TT Glenoid - Screw for Trial Glenosphere AISI 630
• 08033390197274 - ProMade Hip: 2024-03-27 ProMade Hip - Wrench 9 mm
• 08033390275347 - PRIMA TT Glenoid: 2024-03-25 PRIMA TT Glenoid - Modular Reverse TT Baseplate Dia. 25 mm; Full Wedge 15°X
• 08033390275354 - PRIMA TT Glenoid: 2024-03-25 PRIMA TT Glenoid - Modular Reverse TT Baseplate Dia. 25 mm; Full Wedge 20°X
• 08033390260312 - PRIMA TT Glenoid: 2024-03-20 PRIMA TT Glenoid - Central Compressive Screw Cortical Dia. 5 mm L. 20 mm
• 08033390260367 - PRIMA TT Glenoid: 2024-03-20 PRIMA TT Glenoid - Central Compressive Screw Cancellous Dia. 6,5 mm L. 20 mm
• 08033390266536 - PRIMA: 2024-03-20 PRIMA - Short Stem Plus #1