The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Link Embrace Shoulder System- Anatomical Configuration.
| Device ID | K210899 |
| 510k Number | K210899 |
| Device Name: | LINK Embrace Shoulder System- Anatomical Configuration |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Applicant | Waldemar Link GmbH & Co. KG Oststrasse 4-10 Norderstedt, DE 22844 |
| Contact | Stefanie Fuchs |
| Correspondent | Terry Powell LinkBio Corp. 69 King Street Dover, NJ 07801 |
| Product Code | KWT |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWS |
| Subsequent Product Code | PAO |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-26 |
| Decision Date | 2021-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04026575268252 | K210899 | 000 |
| 04026575236336 | K210899 | 000 |
| 04026575236329 | K210899 | 000 |
| 04026575236312 | K210899 | 000 |
| 04026575236282 | K210899 | 000 |
| 04026575236275 | K210899 | 000 |
| 04026575236268 | K210899 | 000 |
| 04026575236251 | K210899 | 000 |
| 04026575236244 | K210899 | 000 |
| 04026575236145 | K210899 | 000 |
| 04026575236138 | K210899 | 000 |
| 04026575236114 | K210899 | 000 |
| 04026575236084 | K210899 | 000 |
| 04026575235933 | K210899 | 000 |
| 04026575235919 | K210899 | 000 |
| 04026575236343 | K210899 | 000 |
| 04026575236350 | K210899 | 000 |
| 04026575236374 | K210899 | 000 |
| 04026575241989 | K210899 | 000 |
| 04026575241927 | K210899 | 000 |
| 04026575241668 | K210899 | 000 |
| 04026575241316 | K210899 | 000 |
| 04026575240111 | K210899 | 000 |
| 04026575240081 | K210899 | 000 |
| 04026575240067 | K210899 | 000 |
| 04026575240050 | K210899 | 000 |
| 04026575240043 | K210899 | 000 |
| 04026575240036 | K210899 | 000 |
| 04026575236473 | K210899 | 000 |
| 04026575236442 | K210899 | 000 |
| 04026575236435 | K210899 | 000 |
| 04026575236398 | K210899 | 000 |
| 04026575198085 | K210899 | 000 |