Shoulder Innovations IM Cut Guide 2R2HC00001

GUDID B1132R2HC000010

Shoulder Innovations - IM Cut Guide - Instrument T-Handle

Shoulder Innovations, Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: B1132R2HC000010
• NIH Device Record Key: 5a7b4bce-77fa-4358-bce8-0f7a8aacdd07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shoulder Innovations IM Cut Guide
• Version Model Number: IM Cut Guide T-Handle
• Catalog Number: 2R2HC00001
• Company DUNS: 080404519
• Company Name: Shoulder Innovations, Inc.
• 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

Customer Support Contacts

• Phone: 616-294-1026
• Email: info@shoulderinnovations.com
• Phone: 616-294-1026
• Email: info@shoulderinnovations.com
• Phone: 616-294-1026
• Email: info@shoulderinnovations.com
• Phone: 616-294-1026
• Email: info@shoulderinnovations.com
• Phone: 616-294-1026
• Email: info@shoulderinnovations.com
• Phone: 616-294-1026
• Email: info@shoulderinnovations.com
• Phone: 616-294-1026
• Email: info@shoulderinnovations.com
• Phone: 616-294-1026
• Email: info@shoulderinnovations.com
• Phone: 616-294-1026
• Email: info@shoulderinnovations.com
• Phone: 616-294-1026
• Email: info@shoulderinnovations.com
• Phone: 616-294-1026
• Email: info@shoulderinnovations.com
• Phone: 616-294-1026
• Email: info@shoulderinnovations.com
• Phone: 616-294-1026
• Email: info@shoulderinnovations.com
• Phone: 616-294-1026
• Email: info@shoulderinnovations.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B1132R2HC000010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102670

FDA Product Code

• MBF: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

Sterilization

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

[B1132R2HC000010]

Moist Heat or Steam Sterilization

[B1132R2HC000010]

Moist Heat or Steam Sterilization

[B1132R2HC000010]

Moist Heat or Steam Sterilization

[B1132R2HC000010]

Moist Heat or Steam Sterilization

[B1132R2HC000010]

Moist Heat or Steam Sterilization

[B1132R2HC000010]

Moist Heat or Steam Sterilization

[B1132R2HC000010]

Moist Heat or Steam Sterilization

[B1132R2HC000010]

Moist Heat or Steam Sterilization

[B1132R2HC000010]

Moist Heat or Steam Sterilization

[B1132R2HC000010]

Moist Heat or Steam Sterilization

[B1132R2HC000010]

Moist Heat or Steam Sterilization

[B1132R2HC000010]

Moist Heat or Steam Sterilization

[B1132R2HC000010]

Moist Heat or Steam Sterilization

[B1132R2HC000010]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-17
• Device Publish Date: 2024-06-07

On-Brand Devices [Shoulder Innovations IM Cut Guide]

• B1132R2HC000040: Shoulder Innovations - IM Cut Guide - Instrument Delto-Pectoral Cut Guide
• B1132R2HC000020: Shoulder Innovations - IM Cut Guide - Instrument Delto-Pectoral Fixed Arm Assembly
• B1132R2HC000010: Shoulder Innovations - IM Cut Guide - Instrument T-Handle
• B1132R2HC000090: Shoulder Innovations - IM Cut Guide Instrument - Subscapularis Sparing Cut Guide Hanger
• B1132R2HC000080: Shoulder Innovations - IM Cut Guide Instrument - Subscapularis Sparing Cut Block Assembly
• B1132R2HC000050: Shoulder Innovations - IM Cut Guide Instrument - Superior-Lateral Fixed Arm Assembly