The following data is part of a premarket notification filed by Biomet, Inc with the FDA for G7 Dual Mobility System, Active Articulation System.
| Device ID | K161190 |
| 510k Number | K161190 |
| Device Name: | G7 Dual Mobility System, Active Articulation System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | Biomet, Inc 56 East Bell Drive Warsaw, IN 46581 -0587 |
| Contact | Emily Manuel |
| Correspondent | Emily Manuel Biomet, Inc 56 East Bell Drive Warsaw, IN 46581 -0587 |
| Product Code | LPH |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LZO |
| Subsequent Product Code | OQG |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-27 |
| Decision Date | 2016-05-26 |
| Summary: | summary |