The following data is part of a premarket notification filed by Corin Orthopedic Products with the FDA for Corin Austin-moore Prosthesis, Modification.
Device ID | K931752 |
510k Number | K931752 |
Device Name: | CORIN AUSTIN-MOORE 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 (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-08 |
Decision Date | 1994-10-07 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05055196928114 | K931752 | 000 |
05055196928008 | K931752 | 000 |
05055196927995 | K931752 | 000 |
05055196927988 | K931752 | 000 |
05055196927971 | K931752 | 000 |
05055196927964 | K931752 | 000 |
05055196927957 | K931752 | 000 |
05055196927940 | K931752 | 000 |
05055196927933 | K931752 | 000 |
05055196928015 | K931752 | 000 |
05055196928022 | K931752 | 000 |
05055196928107 | K931752 | 000 |
05055196928091 | K931752 | 000 |
05055196928084 | K931752 | 000 |
05055196928077 | K931752 | 000 |
05055196928060 | K931752 | 000 |
05055196928053 | K931752 | 000 |
05055196928046 | K931752 | 000 |
05055196928039 | K931752 | 000 |
05055196927926 | K931752 | 000 |