SURGEON SPECIFIC ANATOMIC RESECTION JIG 9CCA.13.005

GUDID 08033390111539

Surgeon specific anatomic resection jig - SMR Shoulder

LIMACORPORATE SPA

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 08033390111539
• NIH Device Record Key: a82cdbaf-ca6d-4760-82ab-2bcdfbfb8829
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURGEON SPECIFIC ANATOMIC RESECTION JIG
• Version Model Number: SURGEON SPECIFIC ANATOMIC RESECTION JIG
• Catalog Number: 9CCA.13.005
• 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	08033390111539 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100858

FDA Product Code

• HSD: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Sterilization

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

[08033390111539]

Moist Heat or Steam Sterilization

[08033390111539]

Moist Heat or Steam Sterilization

[08033390111539]

Moist Heat or Steam Sterilization

[08033390111539]

Moist Heat or Steam Sterilization

[08033390111539]

Moist Heat or Steam Sterilization

[08033390111539]

Moist Heat or Steam Sterilization

[08033390111539]

Moist Heat or Steam Sterilization

[08033390111539]

Moist Heat or Steam Sterilization

[08033390111539]

Moist Heat or Steam Sterilization

[08033390111539]

Moist Heat or Steam Sterilization

[08033390111539]

Moist Heat or Steam Sterilization

[08033390111539]

Moist Heat or Steam Sterilization

[08033390111539]

Moist Heat or Steam Sterilization

[08033390111539]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-05-03
• Device Publish Date: 2016-08-05

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