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 |