The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Fmp Extended Liners.
| Device ID | K172651 |
| 510k Number | K172651 |
| Device Name: | FMP Extended Liners |
| Classification | Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, 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 | OQG |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-05 |
| Decision Date | 2017-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190446200437 | K172651 | 000 |
| 00190446177883 | K172651 | 000 |
| 00190446177890 | K172651 | 000 |
| 00190446177906 | K172651 | 000 |
| 00190446177913 | K172651 | 000 |
| 00190446177920 | K172651 | 000 |
| 00190446177937 | K172651 | 000 |
| 00190446177944 | K172651 | 000 |
| 00190446177951 | K172651 | 000 |
| 00190446177968 | K172651 | 000 |
| 00190446177975 | K172651 | 000 |
| 00190446177982 | K172651 | 000 |
| 00190446180678 | K172651 | 000 |
| 00190446181156 | K172651 | 000 |
| 00190446181163 | K172651 | 000 |
| 00190446181170 | K172651 | 000 |
| 00190446181187 | K172651 | 000 |
| 00190446181194 | K172651 | 000 |
| 00190446177869 | K172651 | 000 |