The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Apc Femoral Component.
Device ID | K926229 |
510k Number | K926229 |
Device Name: | APC FEMORAL COMPONENT |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
Contact | Robert E Smith |
Correspondent | Robert E Smith HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
Product Code | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-11 |
Decision Date | 1994-02-22 |