The following data is part of a premarket notification filed by Osteoremedies, Llc with the FDA for Osteoremedies Hip Spacer System.
| Device ID | K192995 |
| 510k Number | K192995 |
| Device Name: | OsteoRemedies Hip Spacer System |
| 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 20001 |
| Product Code | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2019-10-25 |
| Decision Date | 2020-01-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850011453087 | K192995 | 000 |
| 00850011453070 | K192995 | 000 |
| 00850011453063 | K192995 | 000 |