The following data is part of a premarket notification filed by Serf with the FDA for Bi-mentum Dual Mobility System.
| Device ID | K181744 |
| 510k Number | K181744 |
| Device Name: | BI-MENTUM Dual Mobility System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Serf 85 Avenue Des Bruyeres Decines, FR 69150 |
| Contact | Jean-lus Aurelle |
| Correspondent | Catherine Gloster Gloster Biomedical International 577 N Hope Avenue Santa Barbara, CA 93110 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-02 |
| Decision Date | 2018-12-11 |
| Summary: | summary |