The following data is part of a premarket notification filed by Corin Usa Limited with the FDA for Corin Trifit Cf Hip Stem.
Device ID | K173880 |
510k Number | K173880 |
Device Name: | Corin TriFit CF Hip Stem |
Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
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 | MEH |
Subsequent Product Code | KWL |
Subsequent Product Code | KWY |
Subsequent Product Code | LPH |
Subsequent Product Code | LZO |
Subsequent Product Code | MBL |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-12-21 |
Decision Date | 2018-04-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05056139231162 | K173880 | 000 |
05055343898406 | K173880 | 000 |
05055343898390 | K173880 | 000 |
05055343898383 | K173880 | 000 |
05055343898376 | K173880 | 000 |
05055343898369 | K173880 | 000 |
05055343898352 | K173880 | 000 |
05055343898345 | K173880 | 000 |
05055343898338 | K173880 | 000 |
05055343898321 | K173880 | 000 |
05055343898314 | K173880 | 000 |
05055343898307 | K173880 | 000 |
05055343898291 | K173880 | 000 |
05055343898284 | K173880 | 000 |
05055343898277 | K173880 | 000 |
05055343898260 | K173880 | 000 |
05055343898413 | K173880 | 000 |
05055343898420 | K173880 | 000 |
05056139231155 | K173880 | 000 |
05056139231148 | K173880 | 000 |
05056139231131 | K173880 | 000 |
05056139231124 | K173880 | 000 |
05056139231117 | K173880 | 000 |
05056139231100 | K173880 | 000 |
05056139231094 | K173880 | 000 |
05056139231087 | K173880 | 000 |
05056139231070 | K173880 | 000 |
05056139231063 | K173880 | 000 |
05055343898475 | K173880 | 000 |
05055343898468 | K173880 | 000 |
05055343898451 | K173880 | 000 |
05055343898444 | K173880 | 000 |
05055343898437 | K173880 | 000 |
05056139234187 | K173880 | 000 |