The following data is part of a premarket notification filed by Microport Orthopedics Inc. (mpo) with the FDA for Microport Orthopedics Total Hip Systems Mr Labeling.
| Device ID | K173898 |
| 510k Number | K173898 |
| Device Name: | MicroPort Orthopedics Total Hip Systems MR Labeling |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | MicroPort Orthopedics Inc. (MPO) 5677 Airline Road Arlington, TN 38002 |
| Contact | Usman Rashid |
| Correspondent | Usman Rashid MicroPort Orthopedics Inc. (MPO) 5677 Airline Road Arlington, TN 38002 |
| Product Code | LZO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KXA |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | MAY |
| Subsequent Product Code | MBL |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-22 |
| Decision Date | 2018-09-20 |
| Summary: | summary |