Shoulder Innovations TSA, Humeral Short Stem System 2N1BR00028

GUDID B1132N1BR000280

Shoulder Innovations Project TSA - Humeral Short Stem System - Instrument: Size 0 Rasp

Shoulder Innovations, Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: B1132N1BR000280
• NIH Device Record Key: bf92388f-70ca-4f42-863b-291cfff71fa0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shoulder Innovations TSA, Humeral Short Stem System
• Version Model Number: Size 0
• Catalog Number: 2N1BR00028
• 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: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B1132N1BR000280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102670

FDA Product Code

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

Sterilization

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

[B1132N1BR000280]

Moist Heat or Steam Sterilization

[B1132N1BR000280]

Moist Heat or Steam Sterilization

[B1132N1BR000280]

Moist Heat or Steam Sterilization

[B1132N1BR000280]

Moist Heat or Steam Sterilization

[B1132N1BR000280]

Moist Heat or Steam Sterilization

[B1132N1BR000280]

Moist Heat or Steam Sterilization

[B1132N1BR000280]

Moist Heat or Steam Sterilization

[B1132N1BR000280]

Moist Heat or Steam Sterilization

[B1132N1BR000280]

Moist Heat or Steam Sterilization

[B1132N1BR000280]

Moist Heat or Steam Sterilization

[B1132N1BR000280]

Moist Heat or Steam Sterilization

[B1132N1BR000280]

Moist Heat or Steam Sterilization

[B1132N1BR000280]

Moist Heat or Steam Sterilization

[B1132N1BR000280]

Moist Heat or Steam Sterilization

[B1132N1BR000280]

Moist Heat or Steam Sterilization

[B1132N1BR000280]

Moist Heat or Steam Sterilization

[B1132N1BR000280]

Moist Heat or Steam Sterilization

[B1132N1BR000280]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-11
• Device Publish Date: 2023-10-03

On-Brand Devices [Shoulder Innovations TSA, Humeral Short Stem System]

• B1132N1BR000320: Shoulder Innovations Project TSA - Humeral Short Stem System - Instrument: Full length rasp.
• B1132N1BR000280: Shoulder Innovations Project TSA - Humeral Short Stem System - Instrument: Size 0 Rasp