The following data is part of a premarket notification filed by Sonoma Orthopedic Products, Inc. with the FDA for Sonoma Fibula Repair System.
| Device ID | K142945 |
| 510k Number | K142945 |
| Device Name: | Sonoma Fibula Repair System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | SONOMA ORTHOPEDIC PRODUCTS, INC. 3589 WESTWIND BLVD Santa Rosa, CA 95403 |
| Contact | Rick Epstein |
| Correspondent | Dawn Norman MEMPHIS REGULATORY CONSULTING, LLC 3416 ROXEE RUN COVE Bartlette, TN 38133 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-10 |
| Decision Date | 2015-01-22 |
| Summary: | summary |