The following data is part of a premarket notification filed by Pantheon Medical with the FDA for Pantheon Medical Balanced Plating System.
| Device ID | K162154 |
| 510k Number | K162154 |
| Device Name: | Pantheon Medical Balanced Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | PANTHEON MEDICAL 1505 FEDERAL ST, #300 Dallas, TX 75201 |
| Contact | Travid Bird |
| Correspondent | Lee Strnad INTREPID ORTHOPEDICS, LLC 3046 BRECKSVILLE ROAD SUITE 4 Richfield, OH 44286 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-02 |
| Decision Date | 2017-04-24 |
| Summary: | summary |