The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Empowr Universal Tibial Baseplate.
| Device ID | K173723 |
| 510k Number | K173723 |
| Device Name: | EMPOWR Universal Tibial Baseplate |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758 |
| Contact | Teffany Hutto |
| Correspondent | Teffany Hutto Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-05 |
| Decision Date | 2018-03-05 |
| Summary: | summary |