The following data is part of a premarket notification filed by Disco-o-tech Medical Technologies, Ltd. with the FDA for Fixion Interlocking Nail (fixion Il Nail).
| Device ID | K002783 |
| 510k Number | K002783 |
| Device Name: | FIXION INTERLOCKING NAIL (FIXION IL NAIL) |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. COLUMBIA SQUARE 555 THIRTEENTH STREET, NW Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. COLUMBIA SQUARE 555 THIRTEENTH STREET, NW Washington, DC 20004 -1109 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-06 |
| Decision Date | 2000-12-05 |