The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Trochanteric Dyax Nail System.
Device ID | K013524 |
510k Number | K013524 |
Device Name: | TROCHANTERIC DYAX NAIL SYSTEM |
Classification | Rod, Fixation, Intramedullary And Accessories |
Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
Contact | Karen Ariemma |
Correspondent | Karen Ariemma HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
Product Code | HSB |
CFR Regulation Number | 888.3020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-10-23 |
Decision Date | 2001-11-14 |
Summary: | summary |