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 |