The following data is part of a premarket notification filed by Maxx Orthopedics, Inc. with the FDA for Freedom Ultra-congruent Cr Tibial Liner.
| Device ID | K182574 |
| 510k Number | K182574 |
| Device Name: | Freedom Ultra-Congruent CR Tibial Liner |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Maxx Orthopedics, Inc. 2460 General Armistead Avenue, Suite 100 Norristown, PA 19403 |
| Contact | Priscilla Herpai |
| Correspondent | Priscilla Herpai Maxx Orthopedics, Inc. 2460 General Armistead Avenue, Suite 100 Norristown, PA 19403 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-18 |
| Decision Date | 2019-01-22 |