The following data is part of a premarket notification filed by Disco-o-tech Medical Technologies, Ltd. with the FDA for Fixion Intramedullary Nailing System (fixion Im Nailing System).
| Device ID | K021324 |
| 510k Number | K021324 |
| Device Name: | FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM) |
| 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 | 2002-04-26 |
| Decision Date | 2002-05-23 |
| Summary: | summary |