Shoulder Innovations Humeral Short Stem 2N1HE15048

GUDID B1132N1HE150480

Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial. 15mm x 48mm.

SHOULDER INNOVATIONS, LLC

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• Primary Device ID: B1132N1HE150480
• NIH Device Record Key: 22857e4e-836c-40a0-8fa4-4b4991be9b81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shoulder Innovations Humeral Short Stem
• Version Model Number: 15mm x 48mm
• Catalog Number: 2N1HE15048
• Company DUNS: 080404519
• Company Name: SHOULDER INNOVATIONS, LLC
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B1132N1HE150480 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102670

FDA Product Code

• MBF: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

Sterilization

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

[B1132N1HE150480]

Moist Heat or Steam Sterilization

[B1132N1HE150480]

Moist Heat or Steam Sterilization

[B1132N1HE150480]

Moist Heat or Steam Sterilization

[B1132N1HE150480]

Moist Heat or Steam Sterilization

[B1132N1HE150480]

Moist Heat or Steam Sterilization

[B1132N1HE150480]

Moist Heat or Steam Sterilization

[B1132N1HE150480]

Moist Heat or Steam Sterilization

[B1132N1HE150480]

Moist Heat or Steam Sterilization

[B1132N1HE150480]

Moist Heat or Steam Sterilization

[B1132N1HE150480]

Moist Heat or Steam Sterilization

[B1132N1HE150480]

Moist Heat or Steam Sterilization

[B1132N1HE150480]

Moist Heat or Steam Sterilization

[B1132N1HE150480]

Moist Heat or Steam Sterilization

[B1132N1HE150480]

Moist Heat or Steam Sterilization

[B1132N1HE150480]

Moist Heat or Steam Sterilization

[B1132N1HE150480]

Moist Heat or Steam Sterilization

[B1132N1HE150480]

Moist Heat or Steam Sterilization

[B1132N1HE150480]

Moist Heat or Steam Sterilization

[B1132N1HE150480]

Moist Heat or Steam Sterilization

[B1132N1HE150480]

Moist Heat or Steam Sterilization

[B1132N1HE150480]

Moist Heat or Steam Sterilization

[B1132N1HE150480]

Moist Heat or Steam Sterilization

[B1132N1HE150480]

Moist Heat or Steam Sterilization

[B1132N1HE150480]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-17
• Device Publish Date: 2018-12-17

Devices Manufactured by SHOULDER INNOVATIONS, LLC

• B1132N1AB00003 - SHOULDER INNOVATIONS TSA SYSTEM: 2021-07-08 Instrument Case Base, original Shoulder Innovations case base modified to hold InSet Plus glenoid trials
• B1130S1GG00020 - Shoulder Innovations TSA System: 2021-05-12
• B1130S1GR20065 - SHOULDER INNOVATIONS TSA SYSTEM: 2021-05-12
• B1130S1GR22065 - SHOULDER INNOVATIONS TSA SYSTEM: 2021-05-12
• B1130S1SI20006 - SHOULDER INNOVATIONS TSA SYSTEM: 2021-05-12
• B1130S1SI20008 - SHOULDER INNOVATIONS TSA SYSTEM: 2021-05-12
• B1132N1AC20005 - Shoulder Innovations TSA: 2021-05-12 Shoulder Innovations InSet Plus Glenoid Trial, Circular Center Peg, 20mm x 5°, Stainless Steel
• B1132N1AC20010 - Shoulder Innovations TSA: 2021-05-12 Shoulder Innovations InSet Plus Glenoid Trial, Circular Center Peg, 20mm x 10°, Stainless Steel