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 Nail).
Device ID | K003212 |
510k Number | K003212 |
Device Name: | 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 | Johnathan S Kahan |
Correspondent | Johnathan 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 | 2000-12-28 |