The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Hip Fracture Stem System - Fenestration Plug.
Device ID | K890326 |
510k Number | K890326 |
Device Name: | HIP FRACTURE STEM SYSTEM - FENESTRATION PLUG |
Classification | Cement Obturator |
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 | LZN |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-01-23 |
Decision Date | 1989-02-03 |