The following data is part of a premarket notification filed by Maxx Orthopedics, Inc with the FDA for Libertas Hip Replacement System.
| Device ID | K180973 |
| 510k Number | K180973 |
| Device Name: | Libertas Hip Replacement System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | Maxx Orthopedics, Inc 531 Plymouth Road, Suite 526 Plymouth Meeting, PA 19462 |
| Contact | Corey Perine |
| Correspondent | Hollace Saas Rhodes Musculoskeltal Clinical Regulatory Advisors, LLC 1050 K Street NW Suite 1000 Washington, DC 20001 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-13 |
| Decision Date | 2018-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810008121887 | K180973 | 000 |
| 00810008121870 | K180973 | 000 |
| 00810008121863 | K180973 | 000 |
| 00810008121856 | K180973 | 000 |
| 00810008121849 | K180973 | 000 |
| 00810008121832 | K180973 | 000 |
| 00810008121825 | K180973 | 000 |
| 00810008121818 | K180973 | 000 |