The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Corin Adaptor Sleeve.
| Device ID | K071471 |
| 510k Number | K071471 |
| Device Name: | CORIN ADAPTOR SLEEVE |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Karen Ariemma |
| Correspondent | Karen Ariemma HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-29 |
| Decision Date | 2007-09-10 |
| Summary: | summary |