The following data is part of a premarket notification filed by Mitek Products with the FDA for Rididfix 2.7mm Btb Cross Pin Kit.
Device ID | K013781 |
510k Number | K013781 |
Device Name: | RIDIDFIX 2.7MM BTB CROSS PIN KIT |
Classification | Pin, Fixation, Smooth |
Applicant | MITEK PRODUCTS 249 VANDERBILT AVE. Norwood, MA 02062 |
Contact | Jennifer Johnson |
Correspondent | Jennifer Johnson MITEK PRODUCTS 249 VANDERBILT AVE. Norwood, MA 02062 |
Product Code | HTY |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-11-14 |
Decision Date | 2002-02-06 |
Summary: | summary |