Modulus Hip System 9043.10.360

GUDID 08033390030816

Neck Extractor

LIMACORPORATE SPA

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 08033390030816
• NIH Device Record Key: d148d858-408f-4051-a3cd-7cf420128dda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Modulus Hip System
• Version Model Number: Neck Extractor
• Catalog Number: 9043.10.360
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	08033390030816 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112158

FDA Product Code

• KWY: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Sterilization

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

[08033390030816]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-04-15

Devices Manufactured by LIMACORPORATE SPA

• 08033390282642 - ProMade Shoulder: 2024-08-15 ProMade Shoulder - Long Helix Drill Dia. 3,5 mm
• 08033390282659 - ProMade Shoulder: 2024-08-15 ProMade Shoulder - Guide for Long Helix Drill Dia. 3,5 mm
• 08033390134415 - SMR Shoulder: 2024-08-06 SMR Shoulder - Removal Pliers
• 08033390080637 - SMR Shoulder: 2024-08-05 SMR Shoulder - Reverse liners 36mm (UHMWPE) +6mm
• 08033390085502 - NA: 2024-08-05 Curved Depth Gauge
• 08033390115667 - SMR TT Hybrid Glenoid: 2024-08-05 Hybrid Glenoid Baseplate Small LOW +4 - Peg L
• 08033390115698 - SMR TT Hybrid Glenoid: 2024-08-05 Hybrid Glenoid Baseplate Large LOW +4 - Peg S
• 08033390115711 - SMR TT Hybrid Glenoid: 2024-08-05 Hybrid Glenoid Baseplate Large LOW +4 - Peg L