The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for M.a.r.a. (modular Acetabular Reconstruction Syst).
| Device ID | K911718 |
| 510k Number | K911718 |
| Device Name: | M.A.R.A. (MODULAR ACETABULAR RECONSTRUCTION SYST) |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587 |
| Contact | Patricia M Sandborn |
| Correspondent | Patricia M Sandborn BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-17 |
| Decision Date | 1991-07-16 |