The following data is part of a premarket notification filed by Fusion Innovations, Llc with the FDA for Sternafuse Fixation System.
| Device ID | K202914 |
| 510k Number | K202914 |
| Device Name: | SternaFuse Fixation System |
| Classification | Plate, Fixation, Bone |
| Applicant | Fusion Innovations, LLC 116 E Main Street Suite 201 Rock Hill, SC 29732 |
| Contact | Mark Schumacher |
| Correspondent | Katelyn Jessup Kapstone Medical, LLC 520 Elliot Street Charlotte, NC 28202 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-29 |
| Decision Date | 2022-01-26 |