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 |