The following data is part of a premarket notification filed by Microport Orthopedics Inc. with the FDA for Profemur Tl Classic Long Neck Hip Stems.
| Device ID | K140676 |
| 510k Number | K140676 |
| Device Name: | PROFEMUR TL CLASSIC LONG NECK HIP STEMS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | MICROPORT ORTHOPEDICS INC. 5677 AIRLINE RD Arlington, TN 38002 |
| Contact | Byron Ledbetter |
| Correspondent | Byron Ledbetter MICROPORT ORTHOPEDICS INC. 5677 AIRLINE RD Arlington, TN 38002 |
| Product Code | LZO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LPH |
| Subsequent Product Code | MBL |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-18 |
| Decision Date | 2014-05-30 |