The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Exeter Hip Stem.
| Device ID | K110290 |
| 510k Number | K110290 |
| Device Name: | EXETER HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Valerie Giambanco |
| Correspondent | Valerie Giambanco HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-01 |
| Decision Date | 2011-09-27 |
| Summary: | summary |