The following data is part of a premarket notification filed by Disc-o-tech Medical Technologies, Ltd. with the FDA for Fixion Intramedullary Nailing System (fixion Imn) Model B.
| Device ID | K010901 |
| 510k Number | K010901 |
| Device Name: | FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-26 |
| Decision Date | 2001-06-19 |