The following data is part of a premarket notification filed by Osteoremedies, Llc with the FDA for Remedy Acetabular Cup.
| Device ID | K191981 |
| 510k Number | K191981 |
| Device Name: | REMEDY Acetabular Cup |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | OsteoRemedies, LLC 6800 Poplar Avenue, #120 Germantown, TN 38138 |
| Contact | Eric Stookey |
| Correspondent | Hollace Saas Rhodes MCRA, LLC 1050 K Street NW, Suite 1000 Washington, DC 20005 |
| Product Code | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2019-07-24 |
| Decision Date | 2019-08-23 |