The following data is part of a premarket notification filed by Corin Orthopedic Products with the FDA for Corin Thompson Prosthesis, Modification.
Device ID | K931753 |
510k Number | K931753 |
Device Name: | CORIN THOMPSON PROSTHESIS, MODIFICATION |
Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
Applicant | CORIN ORTHOPEDIC PRODUCTS 10500 UNIVERSITY CENTER DR. SUITE 130 Tampa, FL 33612 |
Contact | Jack Thomas |
Correspondent | Jack Thomas CORIN ORTHOPEDIC PRODUCTS 10500 UNIVERSITY CENTER DR. SUITE 130 Tampa, FL 33612 |
Product Code | KWL |
CFR Regulation Number | 888.3360 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-08 |
Decision Date | 1994-10-07 |