The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Exprt Revision Knee Femoral Augment(5mm), Exprt Revision Knee Stem Extension (40mm).
| Device ID | K161945 |
| 510k Number | K161945 |
| Device Name: | EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm) |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-15 |
| Decision Date | 2016-09-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190446180395 | K161945 | 000 |
| 00190446180388 | K161945 | 000 |
| 00190446180371 | K161945 | 000 |
| 00190446180319 | K161945 | 000 |
| 00190446163077 | K161945 | 000 |