The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Empowr Porous Femur With Hanano Surfacetm.
| Device ID | K210308 |
| 510k Number | K210308 |
| Device Name: | EMPOWR Porous Femur With HAnano SurfaceTM |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | Encore Medical, L.P. 9800 Metric Blvd. Austin, TX 78758 |
| Contact | Christine Chesnutt |
| Correspondent | Christine Chesnutt Encore Medical, L.P. 9800 Metric Blvd. 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 | 2021-02-03 |
| Decision Date | 2021-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190446364610 | K210308 | 000 |
| 00190446364443 | K210308 | 000 |
| 00190446364450 | K210308 | 000 |
| 00190446364467 | K210308 | 000 |
| 00190446364474 | K210308 | 000 |
| 00190446364481 | K210308 | 000 |
| 00190446364498 | K210308 | 000 |
| 00190446364504 | K210308 | 000 |
| 00190446364511 | K210308 | 000 |
| 00190446364528 | K210308 | 000 |
| 00190446364535 | K210308 | 000 |
| 00190446364542 | K210308 | 000 |
| 00190446364559 | K210308 | 000 |
| 00190446364566 | K210308 | 000 |
| 00190446364573 | K210308 | 000 |
| 00190446364580 | K210308 | 000 |
| 00190446364597 | K210308 | 000 |
| 00190446364603 | K210308 | 000 |
| 00190446364399 | K210308 | 000 |