The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Empowr Dual Mobility Metal Liner, Empowr Dual Mobility Poly Bearing.
| Device ID | K203557 |
| 510k Number | K203557 |
| Device Name: | EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| 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 | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-07 |
| Decision Date | 2021-02-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190446669050 | K203557 | 000 |
| 00190446689898 | K203557 | 000 |
| 00190446689881 | K203557 | 000 |
| 00190446689874 | K203557 | 000 |
| 00190446689867 | K203557 | 000 |
| 00190446689850 | K203557 | 000 |
| 00190446689843 | K203557 | 000 |
| 00190446689836 | K203557 | 000 |
| 00190446689829 | K203557 | 000 |
| 00190446689812 | K203557 | 000 |
| 00190446689805 | K203557 | 000 |
| 00190446689799 | K203557 | 000 |
| 00190446689782 | K203557 | 000 |
| 00190446673187 | K203557 | 000 |
| 00190446673194 | K203557 | 000 |
| 00190446673200 | K203557 | 000 |
| 00190446669043 | K203557 | 000 |
| 00190446669036 | K203557 | 000 |
| 00190446669029 | K203557 | 000 |
| 00190446669012 | K203557 | 000 |
| 00190446669005 | K203557 | 000 |
| 00190446668992 | K203557 | 000 |
| 00190446668732 | K203557 | 000 |
| 00190446673255 | K203557 | 000 |
| 00190446673248 | K203557 | 000 |
| 00190446673231 | K203557 | 000 |
| 00190446673224 | K203557 | 000 |
| 00190446673217 | K203557 | 000 |
| 00190446689775 | K203557 | 000 |