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 |