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.
Device ID | K200368 |
510k Number | K200368 |
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 | Stephanie Fuchs |
Correspondent | Terry Powell Link Bio 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 | 2020-02-14 |
Decision Date | 2021-02-05 |