The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Bimobile Dual Mobility System - E-dur Inserts.
| Device ID | K190535 |
| 510k Number | K190535 |
| Device Name: | BiMobile Dual Mobility System - E-Dur Inserts |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Waldemar Link GmbH & Co. KG Oststrasse 4-10 Norderstedt, DE 22844 |
| Contact | Stefanie Fuchs |
| Correspondent | Stefanie Fuchs Waldemar Link GmbH & Co. KG Oststrasse 4-10 Norderstedt, DE 22844 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-04 |
| Decision Date | 2019-08-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04026575279654 | K190535 | 000 |
| 04026575279524 | K190535 | 000 |
| 04026575279531 | K190535 | 000 |
| 04026575279548 | K190535 | 000 |
| 04026575279555 | K190535 | 000 |
| 04026575279562 | K190535 | 000 |
| 04026575279579 | K190535 | 000 |
| 04026575279586 | K190535 | 000 |
| 04026575279593 | K190535 | 000 |
| 04026575279609 | K190535 | 000 |
| 04026575279616 | K190535 | 000 |
| 04026575279623 | K190535 | 000 |
| 04026575279630 | K190535 | 000 |
| 04026575279647 | K190535 | 000 |
| 04026575279517 | K190535 | 000 |