The following data is part of a premarket notification filed by Sonoma Orthopedic Products, Inc. with the FDA for Sonoma Fifth Metatarsal Repair System.
| Device ID | K161371 |
| 510k Number | K161371 |
| Device Name: | Sonoma Fifth Metatarsal Repair System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | SONOMA ORTHOPEDIC PRODUCTS, INC. 1388 BUSCH PARKWAY Buffalo Grove, IL 60089 |
| Contact | Rick Epstein |
| Correspondent | Dawn Norman MRC-X, LLC 6075 Poplar Avenue, Suite 500 Memphis, TN 38119 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-17 |
| Decision Date | 2017-02-24 |
| Summary: | summary |