The following data is part of a premarket notification filed by Osteoremedies Llc with the FDA for Remedy Acetabular Cup.
| Device ID | K173967 |
| 510k Number | K173967 |
| Device Name: | Remedy Acetabular Cup |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | Osteoremedies LLC 6800 Poplar Avenue Suite 120 Memphis, TN 38138 |
| Contact | Chris Hughes |
| Correspondent | Diane Mandell Horwitz Mandell Horwitz Consultants LLC 2995 Steven Martin Drive Fairfax, VA 20031 |
| Product Code | KWL |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2017-12-29 |
| Decision Date | 2018-02-22 |
| Summary: | summary |