The following data is part of a premarket notification filed by Corin Orthopedic Products with the FDA for Corin Bipolar Prosthesis.
| Device ID | K925897 |
| 510k Number | K925897 |
| Device Name: | CORIN BIPOLAR PROSTHESIS |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | CORIN ORTHOPEDIC PRODUCTS C/O HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan CORIN ORTHOPEDIC PRODUCTS C/O HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-19 |
| Decision Date | 1993-08-09 |