The following data is part of a premarket notification filed by Epic Extremity, Llc with the FDA for Epic Extremity Fracture Plate System.
| Device ID | K172441 |
| 510k Number | K172441 |
| Device Name: | EPIC Extremity Fracture Plate System |
| Classification | Plate, Fixation, Bone |
| Applicant | EPIC Extremity, LLC 120 Marguerite Dr, Ste 301 Cranberry Twp, PA 16066 |
| Contact | Dan Schwartzbauer |
| Correspondent | Randy Schlemmer Epic Extremity, LLC 120 Marguerite Dr, Ste 301 Cranberry Twp, PA 16066 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-11 |
| Decision Date | 2017-11-06 |
| Summary: | summary |