The following data is part of a premarket notification filed by Disco-o-tech Medical Technologies, Ltd. with the FDA for Modification Of Fixion Intramedullary Nailing System (fixion Im Nail).
| Device ID | K003215 |
| 510k Number | K003215 |
| Device Name: | MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL) |
| Classification | Nail, Fixation, Bone |
| 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 | JDS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-13 |
| Decision Date | 2000-12-27 |