The following data is part of a premarket notification filed by Ossio Ltd. with the FDA for Ossiofiber Cannulated Trimmable Fixation Nail, Ossiofiber Trimmable Fixation Nail, Ossiofiber Trimmable Fixation Nail, Cannulated Design.
| Device ID | K203465 |
| 510k Number | K203465 |
| Device Name: | OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design |
| Classification | Pin, Fixation, Smooth |
| Applicant | OSSIO Ltd. 8 HaTochen St. Caesarea, IL 3079861 |
| Contact | Taly Lindner |
| Correspondent | David Mcgurl MCRA, LLC 1050 K Street NW, Suite 1000 Washington, DC 20001 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-24 |
| Decision Date | 2021-01-06 |