The following data is part of a premarket notification filed by Disc-o-tech Medical Technologies, Ltd. with the FDA for Metafix And Fixion Fa Intramedullary Nailing Systems.
Device ID | K071679 |
510k Number | K071679 |
Device Name: | METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS |
Classification | Rod, Fixation, Intramedullary And Accessories |
Applicant | DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 11 HAHOSHLIM ST. Herzliya, IL 46724 |
Contact | Yael Rubin |
Correspondent | Yael Rubin DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 11 HAHOSHLIM ST. Herzliya, IL 46724 |
Product Code | HSB |
CFR Regulation Number | 888.3020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-06-19 |
Decision Date | 2007-12-17 |
Summary: | summary |