The following data is part of a premarket notification filed by Maxx Orthopedics, Inc. with the FDA for Freedom Cementless Femoral Component.
| Device ID | K150680 |
| 510k Number | K150680 |
| Device Name: | Freedom Cementless Femoral Component |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | MAXX ORTHOPEDICS, INC. 531 PLYMOUTH RD., SUITE 526 Plymouth Meeting, PA 19462 |
| Contact | Gabriela Gottlieb |
| Correspondent | Gabriela Gottlieb MAXX ORTHOPEDICS, INC. 531 PLYMOUTH RD., SUITE 526 Plymouth Meeting, PA 19462 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-17 |
| Decision Date | 2015-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811767025225 | K150680 | 000 |
| 00811767025058 | K150680 | 000 |
| 00811767025041 | K150680 | 000 |
| 00811767025034 | K150680 | 000 |
| 00811767025027 | K150680 | 000 |
| 00811767025010 | K150680 | 000 |
| 00811767025003 | K150680 | 000 |
| 00811767024990 | K150680 | 000 |
| 00811767024983 | K150680 | 000 |
| 00811767024976 | K150680 | 000 |
| 00811767024969 | K150680 | 000 |
| 00811767024952 | K150680 | 000 |
| 00811767024945 | K150680 | 000 |
| 00811767024938 | K150680 | 000 |
| 00811767024921 | K150680 | 000 |
| 00811767025065 | K150680 | 000 |
| 00811767025072 | K150680 | 000 |
| 00811767025218 | K150680 | 000 |
| 00811767025201 | K150680 | 000 |
| 00811767025195 | K150680 | 000 |
| 00811767025188 | K150680 | 000 |
| 00811767025171 | K150680 | 000 |
| 00811767025164 | K150680 | 000 |
| 00811767025157 | K150680 | 000 |
| 00811767025140 | K150680 | 000 |
| 00811767025133 | K150680 | 000 |
| 00811767025126 | K150680 | 000 |
| 00811767025119 | K150680 | 000 |
| 00811767025102 | K150680 | 000 |
| 00811767025096 | K150680 | 000 |
| 00811767025089 | K150680 | 000 |
| 00811767024914 | K150680 | 000 |