The following data is part of a premarket notification filed by Extremity Medical, Llc. with the FDA for Omni Foot Plating System.
| Device ID | K172260 |
| 510k Number | K172260 |
| Device Name: | Omni Foot Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | Extremity Medical, LLC. 300 Interpace Parkway Suite 410 Parsippany, NJ 07054 |
| Contact | Brian Smekal |
| Correspondent | Brian Smekal Extremity Medical, LLC. 300 Interpace Parkway Suite 410 Parsippany, NJ 07054 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-27 |
| Decision Date | 2017-11-06 |
| Summary: | summary |