The following data is part of a premarket notification filed by Corin Usa Limited with the FDA for Trinity Plus Acetabular Shell.
Device ID | K172551 |
510k Number | K172551 |
Device Name: | Trinity PLUS Acetabular Shell |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
Applicant | Corin USA Limited 12750 Citrus Park Lane Tampa, FL 33625 |
Contact | Rachel King |
Correspondent | Rachel King Corin USA Limited 12750 Citrus Park Lane Tampa, FL 33625 |
Product Code | LPH |
Subsequent Product Code | LZO |
Subsequent Product Code | MBL |
Subsequent Product Code | OQG |
Subsequent Product Code | OQI |
CFR Regulation Number | 888.3358 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-08-23 |
Decision Date | 2018-06-15 |
Summary: | summary |