The following data is part of a premarket notification filed by Maxx Orthopedics, Inc. with the FDA for Freedom Total Knee System.
| Device ID | K082019 |
| 510k Number | K082019 |
| Device Name: | FREEDOM TOTAL KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | MAXX ORTHOPEDICS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane MAXX ORTHOPEDICS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-16 |
| Decision Date | 2009-02-06 |
| Summary: | summary |