The following data is part of a premarket notification filed by Conformis, Inc. with the FDA for Conformis Benefit Hip System.
| Device ID | K190904 |
| 510k Number | K190904 |
| Device Name: | Conformis BeneFIT Hip System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ConforMIS, Inc. 600 Technology Park Billerica, MA 01821 |
| Contact | Emmanuel Nyakako |
| Correspondent | Emmanuel Nyakako ConforMIS, Inc. 600 Technology Park Billerica, MA 01821 |
| Product Code | LPH |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MEH |
| Subsequent Product Code | OQG |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-08 |
| Decision Date | 2019-08-28 |