Shoulder Innovations TSA

GUDID B1132N1KS000150

Steripack Surgical Utility Case Generic

Shoulder Innovations, Inc.

Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis

• Primary Device ID: B1132N1KS000150
• NIH Device Record Key: 4d98e638-63e5-4975-bb3e-7413cddfc082
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shoulder Innovations TSA
• Version Model Number: Surgical Utility Case Generic
• 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
• 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
• 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	B1132N1KS000150 [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

[B1132N1KS000150]

Moist Heat or Steam Sterilization

[B1132N1KS000150]

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[B1132N1KS000150]

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[B1132N1KS000150]

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[B1132N1KS000150]

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[B1132N1KS000150]

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[B1132N1KS000150]

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[B1132N1KS000150]

Moist Heat or Steam Sterilization

[B1132N1KS000150]

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[B1132N1KS000150]

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[B1132N1KS000150]

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[B1132N1KS000150]

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[B1132N1KS000150]

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[B1132N1KS000150]

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[B1132N1KS000150]

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[B1132N1KS000150]

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[B1132N1KS000150]

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[B1132N1KS000150]

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[B1132N1KS000150]

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[B1132N1KS000150]

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[B1132N1KS000150]

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[B1132N1KS000150]

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[B1132N1KS000150]

Moist Heat or Steam Sterilization

[B1132N1KS000150]

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[B1132N1KS000150]

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[B1132N1KS000150]

Moist Heat or Steam Sterilization

[B1132N1KS000150]

Moist Heat or Steam Sterilization

[B1132N1KS000150]

Moist Heat or Steam Sterilization

[B1132N1KS000150]

Moist Heat or Steam Sterilization

[B1132N1KS000150]

Moist Heat or Steam Sterilization

[B1132N1KS000150]

Moist Heat or Steam Sterilization

[B1132N1KS000150]

Moist Heat or Steam Sterilization

[B1132N1KS000150]

Moist Heat or Steam Sterilization

[B1132N1KS000150]

Moist Heat or Steam Sterilization

[B1132N1KS000150]

Moist Heat or Steam Sterilization

[B1132N1KS000150]

Moist Heat or Steam Sterilization

[B1132N1KS000150]

Moist Heat or Steam Sterilization

[B1132N1KS000150]

Moist Heat or Steam Sterilization

[B1132N1KS000150]

Moist Heat or Steam Sterilization

[B1132N1KS000150]

Moist Heat or Steam Sterilization

[B1132N1KS000150]

Moist Heat or Steam Sterilization

[B1132N1KS000150]

Moist Heat or Steam Sterilization

[B1132N1KS000150]

Moist Heat or Steam Sterilization

[B1132N1KS000150]

Moist Heat or Steam Sterilization

[B1132N1KS000150]

Moist Heat or Steam Sterilization

[B1132N1KS000150]

Moist Heat or Steam Sterilization

[B1132N1KS000150]

Moist Heat or Steam Sterilization

[B1132N1KS000150]

Moist Heat or Steam Sterilization

[B1132N1KS000150]

Moist Heat or Steam Sterilization

[B1132N1KS000150]

Moist Heat or Steam Sterilization

[B1132N1KS000150]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-05
• Device Publish Date: 2024-02-26

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.