The following data is part of a premarket notification filed by Disc-o-tech Medical Technologies, Ltd. with the FDA for Modification To Fixion Interlocking Intramedullary Nailing System.
Device ID | K013449 |
510k Number | K013449 |
Device Name: | MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEM |
Classification | Rod, Fixation, Intramedullary And Accessories |
Applicant | DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 3 HASADNAOT Herzelia, IL 46728 |
Contact | Elad Magal |
Correspondent | Elad Magal DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 3 HASADNAOT Herzelia, IL 46728 |
Product Code | HSB |
CFR Regulation Number | 888.3020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-10-17 |
Decision Date | 2001-12-19 |
Summary: | summary |