The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Precision Hip Long Stem Femoral Component System.
Device ID | K873089 |
510k Number | K873089 |
Device Name: | PRECISION HIP LONG STEM FEMORAL COMPONENT SYSTEM |
Classification | Prosthesis, Hip, Femoral Component, Cemented, Metal |
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 | JDG |
CFR Regulation Number | 888.3360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-05 |
Decision Date | 1987-09-16 |