The following data is part of a premarket notification filed by Exremity Medical, Llc. with the FDA for Omni Foot And Ankle Plating System.
| Device ID | K221362 |
| 510k Number | K221362 |
| Device Name: | Omni Foot And Ankle Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | Exremity Medical, LLC. 300 Interpace Parkway, Suite 410 Parsippany, NJ 07054 |
| Contact | Mary Hoffman |
| Correspondent | Mary Hoffman Exremity Medical, LLC. 300 Interpace Parkway, Suite 410 Parsippany, NJ 07054 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-11 |
| Decision Date | 2022-06-10 |