The following data is part of a premarket notification filed by Medacta International S.a. with the FDA for Mototm Partial Knee & Moto Pfj Systems Extension.
| Device ID | K213071 |
| 510k Number | K213071 |
| Device Name: | MOTOTM Partial Knee & MOTO PFJ Systems Extension |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | Medacta International S.A. Strada Regina Castel San Pietro, CH CH-6874 |
| Contact | Stefano Baj |
| Correspondent | Chris Lussier Medacta USA 3973 Delp Street Memphis, TN 38118 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-23 |
| Decision Date | 2021-11-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630345711045 | K213071 | 000 |
| 07630345711670 | K213071 | 000 |
| 07630345711700 | K213071 | 000 |
| 07630345711731 | K213071 | 000 |
| 07630345711762 | K213071 | 000 |
| 07630345711793 | K213071 | 000 |
| 07630345711823 | K213071 | 000 |
| 07630345711885 | K213071 | 000 |
| 07630345711915 | K213071 | 000 |
| 07630345711403 | K213071 | 000 |
| 07630345711373 | K213071 | 000 |
| 07630345711342 | K213071 | 000 |
| 07630345711076 | K213071 | 000 |
| 07630345711106 | K213071 | 000 |
| 07630345711137 | K213071 | 000 |
| 07630345711168 | K213071 | 000 |
| 07630345711199 | K213071 | 000 |
| 07630345711250 | K213071 | 000 |
| 07630345711281 | K213071 | 000 |
| 07630345711311 | K213071 | 000 |
| 07630345711946 | K213071 | 000 |
| 07630345711977 | K213071 | 000 |
| 07630345712394 | K213071 | 000 |
| 07630345712424 | K213071 | 000 |
| 07630345712455 | K213071 | 000 |
| 07630345712516 | K213071 | 000 |
| 07630345712547 | K213071 | 000 |
| 07630345712578 | K213071 | 000 |
| 07630345712608 | K213071 | 000 |
| 07630345712639 | K213071 | 000 |
| 07630345712363 | K213071 | 000 |
| 07630345712332 | K213071 | 000 |
| 07630345712301 | K213071 | 000 |
| 07630345712004 | K213071 | 000 |
| 07630345712035 | K213071 | 000 |
| 07630345712097 | K213071 | 000 |
| 07630345712127 | K213071 | 000 |
| 07630345712158 | K213071 | 000 |
| 07630345712189 | K213071 | 000 |
| 07630345712219 | K213071 | 000 |
| 07630345712240 | K213071 | 000 |
| 07630345712660 | K213071 | 000 |