The following data is part of a premarket notification filed by Encore Medical, L.p. Dba Djo Surgical with the FDA for Porous Patella.
| Device ID | K212941 |
| 510k Number | K212941 |
| Device Name: | Porous Patella |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | Encore Medical, L.P. Dba DJO Surgical 9800 Metric Boulevard Austin, TX 78758 |
| Contact | Michael A Siano |
| Correspondent | Michael A Siano Encore Medical, L.P. Dba DJO Surgical 9800 Metric Boulevard Austin, TX 78758 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-15 |
| Decision Date | 2022-01-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190446365914 | K212941 | 000 |
| 00190446365907 | K212941 | 000 |
| 00190446365891 | K212941 | 000 |
| 00190446337430 | K212941 | 000 |
| 00190446337423 | K212941 | 000 |
| 00190446337416 | K212941 | 000 |
| 00190446337409 | K212941 | 000 |
| 00190446337393 | K212941 | 000 |
| 00190446238843 | K212941 | 000 |