The following data is part of a premarket notification filed by Maxx Orthopedics Inc. with the FDA for Libertas – Taper Uncemented Femoral Stem.
| Device ID | K183684 |
| 510k Number | K183684 |
| Device Name: | Libertas – Taper Uncemented Femoral Stem |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Maxx Orthopedics Inc. 2460 General Armistead Ave, Suite 100 Norristown, PA 19403 |
| Contact | Priscilla Herpai |
| Correspondent | Priscilla Herpai Maxx Orthopedics Inc. 2460 General Armistead Ave, Suite 100 Norristown, PA 19403 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-28 |
| Decision Date | 2019-08-23 |