The following data is part of a premarket notification filed by Corin U.s.a. with the FDA for Taper-fit Total Hip System.
| Device ID | K003666 |
| 510k Number | K003666 |
| Device Name: | TAPER-FIT TOTAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612 |
| Contact | Joel K Batts |
| Correspondent | Joel K Batts CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-28 |
| Decision Date | 2001-02-08 |
| Summary: | summary |