The following data is part of a premarket notification filed by Osteoremedies Llc with the FDA for Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer.
| Device ID | K183017 |
| 510k Number | K183017 |
| Device Name: | Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| 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 | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2018-10-31 |
| Decision Date | 2019-07-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855195006708 | K183017 | 000 |
| 00855195006692 | K183017 | 000 |
| 00855195006685 | K183017 | 000 |
| 00855195006678 | K183017 | 000 |
| 00855195006661 | K183017 | 000 |
| 00855195006654 | K183017 | 000 |
| 00855195006647 | K183017 | 000 |
| 00855195006630 | K183017 | 000 |
| 00855195006623 | K183017 | 000 |