TOTAL SHOULDER SYSTEM

Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

SHOULDER INNOVATIONS, LLC

The following data is part of a premarket notification filed by Shoulder Innovations, Llc with the FDA for Total Shoulder System.

Pre-market Notification Details

• Device ID: K102670
• 510k Number: K102670
• Device Name: TOTAL SHOULDER SYSTEM
• Classification: Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
• Applicant: SHOULDER INNOVATIONS, LLC 4670 FULTON STREET EAST SUITE 202 Ada, MI 49301
• Contact: Andrew Rodenhouse
• Correspondent: Andrew Rodenhouse; SHOULDER INNOVATIONS, LLC 4670 FULTON STREET EAST SUITE 202 Ada, MI 49301
• Product Code: KWS
• Subsequent Product Code: HSD
• Subsequent Product Code: KWT
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-09-16
• Decision Date: 2011-01-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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B1130S0CI270060	K102670	000
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