The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Bimobile Instruments (for Bimobile Dual Mobility System).
| Device ID | K211567 |
| 510k Number | K211567 |
| Device Name: | BiMobile Instruments (for BiMobile Dual Mobility System) |
| 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 | Stefani Fuchs LinkBio Corp. Oststraße 4-10 Nordertedt, DE 22844 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-21 |
| Decision Date | 2022-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04026575439478 | K211567 | 000 |
| 04026575439324 | K211567 | 000 |
| 04026575439331 | K211567 | 000 |
| 04026575439348 | K211567 | 000 |
| 04026575439355 | K211567 | 000 |
| 04026575439362 | K211567 | 000 |
| 04026575439379 | K211567 | 000 |
| 04026575439386 | K211567 | 000 |
| 04026575439393 | K211567 | 000 |
| 04026575439409 | K211567 | 000 |
| 04026575439416 | K211567 | 000 |
| 04026575439423 | K211567 | 000 |
| 04026575439430 | K211567 | 000 |
| 04026575439447 | K211567 | 000 |
| 04026575439454 | K211567 | 000 |
| 04026575439461 | K211567 | 000 |
| 04026575439317 | K211567 | 000 |