The following data is part of a premarket notification filed by Microport Orthopedics Inc with the FDA for Procotyl® Prime Acetabular Cup System.
| Device ID | K170444 |
| 510k Number | K170444 |
| Device Name: | PROCOTYL® PRIME Acetabular Cup System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | MicroPort Orthopedics Inc 5677 Airline Road Arlington, TN 38002 |
| Contact | Kaitlin Grove |
| Correspondent | Kaitlin Grove 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 | 2017-02-14 |
| Decision Date | 2017-06-26 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PROCOTYL 78558986 3163841 Live/Registered |
Wright Medical Technology, Inc. 2005-02-02 |