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.
Device ID | K990717 |
510k Number | K990717 |
Device Name: | FIXION INTRAMEDULLARY NAILING SYSTEM |
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 | 1999-03-04 |
Decision Date | 1999-06-02 |
Summary: | summary |