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 |