The following data is part of a premarket notification filed by Omnia Medical, Llc with the FDA for Omnia Medical Trauma Screws.
| Device ID | K192096 |
| 510k Number | K192096 |
| Device Name: | Omnia Medical Trauma Screws |
| Classification | Screw, Fixation, Bone |
| Applicant | Omnia Medical, LLC 6 Canyon Rd Suite 300 Morgantown, WV 26508 |
| Contact | Troy Schifano |
| Correspondent | Daniel Johnson JALEX Medical 30311 Clemens Rd Suite 5D Westlake, OH 44145 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-05 |
| Decision Date | 2020-02-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00843511100742 | K192096 | 000 |
| 00843511123000 | K192096 | 000 |
| 00843511122997 | K192096 | 000 |
| 00843511122980 | K192096 | 000 |
| 00843511122973 | K192096 | 000 |
| 00843511122966 | K192096 | 000 |
| 00843511122959 | K192096 | 000 |
| 00843511122942 | K192096 | 000 |
| 00843511122935 | K192096 | 000 |
| 00843511122928 | K192096 | 000 |
| 00843511122911 | K192096 | 000 |
| 00843511122904 | K192096 | 000 |
| 00843511122898 | K192096 | 000 |
| 00843511122881 | K192096 | 000 |
| 00843511123017 | K192096 | 000 |
| 00843511100759 | K192096 | 000 |
| 00843511100735 | K192096 | 000 |
| 00843511100872 | K192096 | 000 |
| 00843511100865 | K192096 | 000 |
| 00843511100858 | K192096 | 000 |
| 00843511100841 | K192096 | 000 |
| 00843511100834 | K192096 | 000 |
| 00843511100827 | K192096 | 000 |
| 00843511100810 | K192096 | 000 |
| 00843511100803 | K192096 | 000 |
| 00843511100797 | K192096 | 000 |
| 00843511100780 | K192096 | 000 |
| 00843511100773 | K192096 | 000 |
| 00843511100766 | K192096 | 000 |
| 00843511122874 | K192096 | 000 |