Shoulder Innovations TSA, Humeral Short Stem System 2N1BR00032

GUDID B1132N1BR000320

Shoulder Innovations Project TSA - Humeral Short Stem System - Instrument: Full length rasp.

Shoulder Innovations, Inc.

Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: B1132N1BR000320
• NIH Device Record Key: 9c1b5c39-949e-4080-96d2-9d2fc09ff104
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shoulder Innovations TSA, Humeral Short Stem System
• Version Model Number: 32
• Catalog Number: 2N1BR00032
• 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
• 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	B1132N1BR000320 [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

[B1132N1BR000320]

Moist Heat or Steam Sterilization

[B1132N1BR000320]

Moist Heat or Steam Sterilization

[B1132N1BR000320]

Moist Heat or Steam Sterilization

[B1132N1BR000320]

Moist Heat or Steam Sterilization

[B1132N1BR000320]

Moist Heat or Steam Sterilization

[B1132N1BR000320]

Moist Heat or Steam Sterilization

[B1132N1BR000320]

Moist Heat or Steam Sterilization

[B1132N1BR000320]

Moist Heat or Steam Sterilization

[B1132N1BR000320]

Moist Heat or Steam Sterilization

[B1132N1BR000320]

Moist Heat or Steam Sterilization

[B1132N1BR000320]

Moist Heat or Steam Sterilization

[B1132N1BR000320]

Moist Heat or Steam Sterilization

[B1132N1BR000320]

Moist Heat or Steam Sterilization

[B1132N1BR000320]

Moist Heat or Steam Sterilization

[B1132N1BR000320]

Moist Heat or Steam Sterilization

[B1132N1BR000320]

Moist Heat or Steam Sterilization

[B1132N1BR000320]

Moist Heat or Steam Sterilization

[B1132N1BR000320]

Moist Heat or Steam Sterilization

[B1132N1BR000320]

Moist Heat or Steam Sterilization

[B1132N1BR000320]

Moist Heat or Steam Sterilization

[B1132N1BR000320]

Moist Heat or Steam Sterilization

[B1132N1BR000320]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-08-10
• Device Publish Date: 2019-07-31

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