The following data is part of a premarket notification filed by Disco-o-tech Medical Technologies, Ltd. with the FDA for Fixion Dynamic Hip Screw System (fixion Dhs).
Device ID | K031401 |
510k Number | K031401 |
Device Name: | FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS) |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
Applicant | DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. 3 HASADNOAT ST. Herzlia, IL 46728 |
Contact | Yael Rubin |
Correspondent | Yael Rubin DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. 3 HASADNOAT ST. Herzlia, IL 46728 |
Product Code | KTT |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-05-05 |
Decision Date | 2003-08-06 |
Summary: | summary |