Shoulder Innovations TSA 2N2AI33005

GUDID B1132N2AI330050

Shoulder Innovations InSet Plus Glenoid Implant, Circular In Line Peg, 33mm x 5°, UHMWPE

Shoulder Innovations, Inc.

Total shoulder prosthesis

• Primary Device ID: B1132N2AI330050
• NIH Device Record Key: 65bc137d-3d3f-4e0b-a5d0-04e09a6dd9a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shoulder Innovations TSA
• Version Model Number: 33 mm x 5°
• Catalog Number: 2N2AI33005
• 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: true
• 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: 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	B1132N2AI330050 [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: true

[B1132N2AI330050]

Ethylene Oxide

[B1132N2AI330050]

Ethylene Oxide

[B1132N2AI330050]

Ethylene Oxide

[B1132N2AI330050]

Ethylene Oxide

[B1132N2AI330050]

Ethylene Oxide

[B1132N2AI330050]

Ethylene Oxide

[B1132N2AI330050]

Ethylene Oxide

[B1132N2AI330050]

Ethylene Oxide

[B1132N2AI330050]

Ethylene Oxide

[B1132N2AI330050]

Ethylene Oxide

[B1132N2AI330050]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-06
• Device Publish Date: 2024-04-27

On-Brand Devices [Shoulder Innovations TSA]

• B1132N1KS000010: Steripack Surgical Utility Case
• B1132N2AI200100: Shoulder Innovations InSet Plus Glenoid Implant, Circular In Line Peg, 20mm x 10°, UHMWPE
• B1132N2AI200050: Shoulder Innovations InSet Plus Glenoid Implant, Circular In Line Peg, 20mm x 5°, UHMWPE
• B1130S0CI200080: Shoulder Innovations - TSA. Glenoid Circular In Line Peg. 20m x 8mm. UHMWPE.
• B1130S0CI200060: Shoulder Innovations - TSA. Glenoid Circular In Line Peg. 20m x 6mm. UHMWPE.
• B1132N1KS000150: Steripack Surgical Utility Case Generic
• B1132N2AI330100: Shoulder Innovations InSet Plus Glenoid Implant, Circular In Line Peg, 33mm x 10°, UHMWPE
• B1132N2AI330050: Shoulder Innovations InSet Plus Glenoid Implant, Circular In Line Peg, 33mm x 5°, UHMWPE
• B1132N1AI330100: Shoulder Innovations InSet Plus Glenoid Trial, Circular In Line Peg, 33mm x 10°, Stainless Stee
• B1132N1AI330050: Shoulder Innovations InSet Plus Glenoid Trial, Circular In Line Peg, 33mm x 5°, Stainless Steel
• B1132N1AC330100: Shoulder Innovations InSet Plus Glenoid Trial, Circular Center Peg, 33mm x 10°, Stainless Steel
• B1132N1AC330050: Shoulder Innovations InSet Plus Glenoid Trial, Circular Center Peg, 33mm x 5°, Stainless Steel
• B1130S0CI330080: Shoulder Innovations - TSA. Glenoid Circular In Line Peg. 33 mm x 8 mm. UHMWPE.
• B1130S0CI330060: Shoulder Innovations - TSA. Glenoid Circular In Line Peg. 33mm x 6mm. UHMWPE.