The following data is part of a premarket notification filed by Osteoremedies, Llc with the FDA for Remedy Plus Hip Spacer, Unite Plus Bone Cement.
| Device ID | K172906 |
| 510k Number | K172906 |
| Device Name: | REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | OsteoRemedies, LLC 6800 Poplar Avenue, #120 Germantown, TN 38138 |
| Contact | Eric Stookey |
| Correspondent | Hollace Saas Rhodes Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street, Suite 1000 Washington, DC 20001 |
| Product Code | KWL |
| Subsequent Product Code | KWY |
| Subsequent Product Code | MBB |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2017-09-22 |
| Decision Date | 2018-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855195006616 | K172906 | 000 |
| 00855195006531 | K172906 | 000 |
| 00855195006548 | K172906 | 000 |
| 00855195006555 | K172906 | 000 |
| 00855195006562 | K172906 | 000 |
| 00855195006579 | K172906 | 000 |
| 00855195006586 | K172906 | 000 |
| 00855195006593 | K172906 | 000 |
| 00855195006609 | K172906 | 000 |
| 00855195006524 | K172906 | 000 |