The following data is part of a premarket notification filed by Disco-o-tech Medical Technologies, Ltd. with the FDA for Modification To Fixion Intramedullary Nailing System (fixion Im).
Device ID | K032588 |
510k Number | K032588 |
Device Name: | MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM) |
Classification | Rod, Fixation, Intramedullary And Accessories |
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 | HSB |
CFR Regulation Number | 888.3020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-08-22 |
Decision Date | 2003-09-12 |
Summary: | summary |