The following data is part of a premarket notification filed by Cintor Orthopaedic Div. with the FDA for Orthofix Axialexternal Fixation Sys..
Device ID | K802814 |
510k Number | K802814 |
Device Name: | ORTHOFIX AXIALEXTERNAL FIXATION SYS. |
Classification | Component, Traction, Invasive |
Applicant | CINTOR ORTHOPAEDIC DIV. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JEC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-11-07 |
Decision Date | 1980-12-10 |