Shoulder Innovations InSet FxR 185 Humeral Stem Trial 2L2HB28508

GUDID B1132L2HB285080

Shoulder Innovations - InSet FxR 185 Humeral Stem Trial - 8mm

Shoulder Innovations, Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: B1132L2HB285080
• NIH Device Record Key: e8d12330-3af5-4827-8825-7022dcc3fddb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shoulder Innovations InSet FxR 185 Humeral Stem Trial
• Version Model Number: 8mmX185 Humeral Stem Trial
• Catalog Number: 2L2HB28508
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B1132L2HB285080 [Primary]

FDA Product Code

• KWT: Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Sterilization

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

[B1132L2HB285080]

Moist Heat or Steam Sterilization

[B1132L2HB285080]

Moist Heat or Steam Sterilization

[B1132L2HB285080]

Moist Heat or Steam Sterilization

[B1132L2HB285080]

Moist Heat or Steam Sterilization

[B1132L2HB285080]

Moist Heat or Steam Sterilization

[B1132L2HB285080]

Moist Heat or Steam Sterilization

[B1132L2HB285080]

Moist Heat or Steam Sterilization

[B1132L2HB285080]

Moist Heat or Steam Sterilization

[B1132L2HB285080]

Moist Heat or Steam Sterilization

[B1132L2HB285080]

Moist Heat or Steam Sterilization

[B1132L2HB285080]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-22
• Device Publish Date: 2025-12-12

On-Brand Devices [Shoulder Innovations InSet FxR 185 Humeral Stem Trial]

• B1132L2HB285120: Shoulder Innovations - InSet FxR 185 Humeral Stem Trial - 12mm
• B1132L2HB285100: Shoulder Innovations - InSet FxR 185 Humeral Stem Trial - 10mm
• B1132L2HB285080: Shoulder Innovations - InSet FxR 185 Humeral Stem Trial - 8mm
• B1132L2HB285060: Shoulder Innovations - InSet FxR 185 Humeral Stem Trial - 6mm