The following data is part of a premarket notification filed by Corin Usa with the FDA for Corin Minihip Stem.
Device ID | K131986 |
510k Number | K131986 |
Device Name: | CORIN MINIHIP STEM |
Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
Applicant | CORIN USA 5670 W. CYPRESS ST. SUITE C Tampa, FL 33607 |
Contact | Lucinda Gerber |
Correspondent | Lucinda Gerber CORIN USA 5670 W. CYPRESS ST. SUITE C Tampa, FL 33607 |
Product Code | LZO |
Subsequent Product Code | KWL |
Subsequent Product Code | MEH |
Subsequent Product Code | OQI |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-06-28 |
Decision Date | 2013-12-16 |
Summary: | summary |