Shoulder Innovations InSet FxR 185 2L1S100003

GUDID B1132L1S1000030

Shoulder Innovations - InSet FxR 185 -10mmX185

Shoulder Innovations, Inc.

Total shoulder prosthesis

• Primary Device ID: B1132L1S1000030
• NIH Device Record Key: ad4f85b8-7194-4694-bc77-10926e04f037
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shoulder Innovations InSet FxR 185
• Version Model Number: 10mmX185
• Catalog Number: 2L1S100003
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B1132L1S1000030 [Primary]

FDA Product Code

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

Sterilization

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

[B1132L1S1000030]

Radiation Sterilization

[B1132L1S1000030]

Radiation Sterilization

[B1132L1S1000030]

Radiation Sterilization

[B1132L1S1000030]

Radiation Sterilization

[B1132L1S1000030]

Radiation Sterilization

[B1132L1S1000030]

Radiation Sterilization

[B1132L1S1000030]

Radiation Sterilization

[B1132L1S1000030]

Radiation Sterilization

[B1132L1S1000030]

Radiation Sterilization

[B1132L1S1000030]

Radiation Sterilization

[B1132L1S1000030]

Radiation 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]

• B1132L1S1200030: Shoulder Innovations - InSet FxR 185 -12mmX185
• B1132L1S1000030: Shoulder Innovations - InSet FxR 185 -10mmX185
• B1132L1S0800030: Shoulder Innovations - InSet FxR 185 - 8mmX185
• B1132L1S0600030: Shoulder Innovations - InSet FxR 185 - 6mmX185