Shoulder Innovations Humeral Short Stem System 2N1IN10056

GUDID B1132N1IN100560

Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Open Norris Ring Guide

Shoulder Innovations, Inc.

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• Primary Device ID: B1132N1IN100560
• NIH Device Record Key: bd30056c-0928-4849-9118-4e5146d7fb63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shoulder Innovations Humeral Short Stem System
• Version Model Number: 56mm Open Norris Ring
• Catalog Number: 2N1IN10056
• 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: 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
• 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	B1132N1IN100560 [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

[B1132N1IN100560]

Moist Heat or Steam Sterilization

[B1132N1IN100560]

Moist Heat or Steam Sterilization

[B1132N1IN100560]

Moist Heat or Steam Sterilization

[B1132N1IN100560]

Moist Heat or Steam Sterilization

[B1132N1IN100560]

Moist Heat or Steam Sterilization

[B1132N1IN100560]

Moist Heat or Steam Sterilization

[B1132N1IN100560]

Moist Heat or Steam Sterilization

[B1132N1IN100560]

Moist Heat or Steam Sterilization

[B1132N1IN100560]

Moist Heat or Steam Sterilization

[B1132N1IN100560]

Moist Heat or Steam Sterilization

[B1132N1IN100560]

Moist Heat or Steam Sterilization

[B1132N1IN100560]

Moist Heat or Steam Sterilization

[B1132N1IN100560]

Moist Heat or Steam Sterilization

[B1132N1IN100560]

Moist Heat or Steam Sterilization

[B1132N1IN100560]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-06
• Device Publish Date: 2023-09-28

On-Brand Devices [Shoulder Innovations Humeral Short Stem System]

• B1132N1IT100000: Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Multi-Use T-handle.
• B1132N1IN000560: Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Ring Guide
• B1132N1IN000520: Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Ring Guide.
• B1132N1IN000480: Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Ring Guide
• B1132N1IN000440: Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Ring Guide.
• B1132N1IN000400: Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Ring Guide.
• B1132N2SN062801: Shoulder Innovations - TSA - Humeral Short Stem System. Titanium short stem. 28mm x 6mm.
• B1132N1IM000100: Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Impaction Stand Assembly
• B1132N1IP004500: Shoulder Innovations - TSA - Humeral Short Stem. Instrument. Spiked Humeral Cut Protector - 45
• B1132N1IP004250: Shoulder Innovations - TSA - Humeral Short Stem. Instrument. Spiked Humeral Cut Protector - 42
• B1132N1IP003750: Shoulder Innovations - TSA - Humeral Short Stem. Instrument. Spiked Humeral Cut Protector - 37
• B1132N1IN100560: Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Open Norris Ring Guide
• B1132N1IN100520: Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Open Norris Ring Guide.
• B1132N1IN100480: Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Open Norris Ring Guide
• B1132N1IN100440: Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Open Norris Ring Guide.
• B1132N1IN100400: Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Open Norris Ring Guide.
• B1132N2HE140381: Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 14mm High x 38mm Diamete
• B1132N1HE140381: Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Trial Head. 14mm x 38mm.
• B1132N1IA000010: Shoulder Innovations - TSA - Humeral Short Stem System. Instrument: K-Wire 1.6mm
• B1132N1HG00000: Shoulder Innovations - TSA - Humeral Short Stem System. Instrument: K-Wire Guide
• B1132N1HG000000: Shoulder Innovations - TSA - Humeral Short Stem System. Instrument: K-Wire Guide
• B1132N1HE140380: Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Trial Head. 14mm x 38mm.
• B1130S1GK000020: Shoulder Innovations - TSA - Humeral Short Stem System. Instrument: K-Wire Guide 2.4 mm
• B1132N2SN064400: Shoulder Innovations - TSA - Humeral Short Stem System. Titanium short stem. 44mm x 6mm.
• B1132N2SN063800: Shoulder Innovations - TSA - Humeral Short Stem System. Titanium short stem. 38mm x 6mm.
• B1132N2SN063200: Shoulder Innovations - TSA - Humeral Short Stem System. Titanium short stem. 32 mm x 6mm.
• B1132N2SN062800: Shoulder Innovations - TSA - Humeral Short Stem System. Titanium short stem. 28mm x 6mm.