The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Howmedica Femoral Component Hip Sys 6259.
Device ID | K851566 |
510k Number | K851566 |
Device Name: | HOWMEDICA FEMORAL COMPONENT HIP SYS 6259 |
Classification | Prosthesis, Hip, Femoral Component, Cemented, Metal |
Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
Contact | James L Barbarito |
Correspondent | James L Barbarito HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
Product Code | JDG |
CFR Regulation Number | 888.3360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-16 |
Decision Date | 1985-07-30 |