The following data is part of a premarket notification filed by Microport Orthopedics Inc. with the FDA for Prime Acetabular Cup System.
| Device ID | K180798 |
| 510k Number | K180798 |
| Device Name: | Prime Acetabular Cup System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | MicroPort Orthopedics Inc. 5677 Airline Road Arlington, TN 38002 |
| Contact | Sarah Evonne Stroupe |
| Correspondent | Sarah Evonne Stroupe MicroPort Orthopedics Inc. 5677 Airline Road Arlington, TN 38002 |
| Product Code | LPH |
| Subsequent Product Code | HWC |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-27 |
| Decision Date | 2018-07-09 |
| Summary: | summary |