The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Alteon Modular Dual Mobility (mdm) System.
| Device ID | K190890 |
| 510k Number | K190890 |
| Device Name: | Exactech Alteon Modular Dual Mobility (MDM) System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Exactech, Inc. 2320 NW 66th Court Gainesville, FL 32653 |
| Contact | Liz Howell |
| Correspondent | Liz Howell Exactech, Inc. 2320 NW 66th Court Gainesville, FL 32653 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-05 |
| Decision Date | 2019-10-22 |
| Summary: | summary |