LINK® Embrace Shoulder System - Reverse Configuration

Shoulder Prosthesis, Reverse Configuration

Waldemar Link GmbH & Co. KG

The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Link® Embrace Shoulder System - Reverse Configuration.

Pre-market Notification Details

• Device ID: K212992
• 510k Number: K212992
• Device Name: LINK® Embrace Shoulder System - Reverse Configuration
• Classification: Shoulder Prosthesis, Reverse Configuration
• Applicant: Waldemar Link GmbH & Co. KG Ostsraße 4-10 Norderstedt, DE 22844
• Contact: Stefanie Fuchs
• Correspondent: Terry Powell; LinkBio Corp 69 King Street Dover, NJ 07801
• Product Code: PHX
• Subsequent Product Code: HSD
• Subsequent Product Code: PAO
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-09-20
• Decision Date: 2021-11-18