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 |