The following data is part of a premarket notification filed by Fusion Orthopedics, Llc with the FDA for Fusion Silastic System.
| Device ID | K190136 |
| 510k Number | K190136 |
| Device Name: | Fusion Silastic System |
| Classification | Prosthesis, Toe, Constrained, Polymer |
| Applicant | Fusion Orthopedics, LLC 4135 S. Power Rd., Suite 110 Mesa, AZ 85212 |
| Contact | Eli Jacobson |
| Correspondent | Eli Jacobson Fusion Orthopedics, LLC 4135 S. Power Rd., Suite 110 Mesa, AZ 85212 |
| Product Code | KWH |
| CFR Regulation Number | 888.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-29 |
| Decision Date | 2019-10-21 |
| Summary: | summary |