The following data is part of a premarket notification filed by Corin Usa with the FDA for Corin Trinity Acetbular System With Hxlpe Liners.
Device ID | K110087 |
510k Number | K110087 |
Device Name: | CORIN TRINITY ACETBULAR SYSTEM WITH HXLPE LINERS |
Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
Applicant | CORIN USA 10500 UNIVERSITY CENTER DRIVE SUITE 190 Tampa, FL 33612 |
Contact | Lucinda Gerber |
Correspondent | Lucinda Gerber CORIN USA 10500 UNIVERSITY CENTER DRIVE SUITE 190 Tampa, FL 33612 |
Product Code | LZO |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-01-12 |
Decision Date | 2011-05-03 |
Summary: | summary |