Humelock Cemented Shoulder Prosthesis 926-1016

GUDID 03701037306970

TRIAL OFFSET HEAD 35x15

FX SOLUTIONS

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03701037306970
• NIH Device Record Key: 479196bf-73c4-4039-b618-19badeed3cd6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Humelock Cemented Shoulder Prosthesis
• Version Model Number: 926-1016
• Catalog Number: 926-1016
• Company DUNS: 263076196
• Company Name: FX SOLUTIONS
• 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 Dimensions

• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture
• Special Storage Condition, Specify: Between 0 and 0 *Store away from light and sunlight Store away from moisture

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701037306970 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111097

FDA Product Code

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

Sterilization

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

[03701037306970]

Moist Heat or Steam Sterilization

[03701037306970]

Moist Heat or Steam Sterilization

[03701037306970]

Moist Heat or Steam Sterilization

[03701037306970]

Moist Heat or Steam Sterilization

[03701037306970]

Moist Heat or Steam Sterilization

[03701037306970]

Moist Heat or Steam Sterilization

[03701037306970]

Moist Heat or Steam Sterilization

[03701037306970]

Moist Heat or Steam Sterilization

[03701037306970]

Moist Heat or Steam Sterilization

[03701037306970]

Moist Heat or Steam Sterilization

[03701037306970]

Moist Heat or Steam Sterilization

[03701037306970]

Moist Heat or Steam Sterilization

[03701037306970]

Moist Heat or Steam Sterilization

[03701037306970]

Moist Heat or Steam Sterilization

[03701037306970]

Moist Heat or Steam Sterilization

[03701037306970]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-10-07
• Device Publish Date: 2018-09-17

On-Brand Devices [Humelock Cemented Shoulder Prosthesis]

• 03701037306994: TRIAL OFFSET HEAD 48x19
• 03701037306987: TRIAL OFFSET HEAD 41x16
• 03701037306970: TRIAL OFFSET HEAD 35x15
• 03701037306963: TRIAL CENTERED HEAD 54X20
• 03701037306956: TRIAL CENTERED HEAD 48x18
• 03701037306949: TRIAL CENTERED HEAD 41x15
• 03701037306932: TRIAL CENTERED HEAD 35x14
• 03701037305546: HUMELOCK RETROVERSION STEM
• 03701037303634: TRIAL OFFSET HEAD 50x20
• 03701037303627: TRIAL OFFSET HEAD 46x18
• 03701037303603: TRIAL OFFSET HEAD 39x15
• 03701037303597: TRIAL CENTERED HEAD 50x19
• 03701037303580: TRIAL CENTERED HEAD 46x17
• 03701037303573: TRIAL CENTERED HEAD 43x16
• 03701037303566: TRIAL CENTERED HEAD 39x14
• 03701037300497: Humelock Cemented Shoulder Prosthesis, OFFSET HEAD CrCo 46x18
• 03701037300480: OFFSET HEAD CrCo 43x17
• 03701037300466: Humelock Cemented Shoulder Prosthesis, OFFSET HEAD CrCo 39x15
• 03701037300435: Humelock Cemented Shoulder Prosthesis, CENTERED HEAD CrCo 50x19
• 03701037300411: Humelock Cemented Shoulder Prosthesis, CENTERED HEAD CrCo 46x17
• 03701037300404: Humelock Cemented Shoulder Prosthesis, CENTERED HEAD CrCo 43x16
• 03701037300381: Humelock Cemented Shoulder Prosthesis, CENTERED HEAD CrCo 39x14