Shoulder Innovations InSet FxR 135 2L1S060002

GUDID B1132L1S0600020

Shoulder Innovations - InSet FxR 135 - 6mmX135

Shoulder Innovations, Inc.

Total shoulder prosthesis

• Primary Device ID: B1132L1S0600020
• NIH Device Record Key: a157afba-68b0-446d-8f61-18297995e394
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shoulder Innovations InSet FxR 135
• Version Model Number: 6mmX135
• Catalog Number: 2L1S060002
• 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	B1132L1S0600020 [Primary]

FDA Product Code

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

Sterilization

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

[B1132L1S0600020]

Radiation Sterilization

[B1132L1S0600020]

Radiation Sterilization

[B1132L1S0600020]

Radiation Sterilization

[B1132L1S0600020]

Radiation Sterilization

[B1132L1S0600020]

Radiation Sterilization

[B1132L1S0600020]

Radiation Sterilization

[B1132L1S0600020]

Radiation Sterilization

[B1132L1S0600020]

Radiation Sterilization

[B1132L1S0600020]

Radiation Sterilization

[B1132L1S0600020]

Radiation Sterilization

[B1132L1S0600020]

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 135]

• B1132L1S1200020: Shoulder Innovations - InSet FxR 135 -12mmX135
• B1132L1S1000020: Shoulder Innovations - InSet FxR 135 -10mmX135
• B1132L1S0800020: Shoulder Innovations - InSet FxR 135 - 8mmX135
• B1132L1S0600020: Shoulder Innovations - InSet FxR 135 - 6mmX135
• B1132L1S0400020: Shoulder Innovations - InSet FxR 135 - 4mmX135