The following data is part of a premarket notification filed by Sonoma Orthopedics Products, Inc with the FDA for Sonoma Cancellous Bone Screw And Washer.
| Device ID | K150376 |
| 510k Number | K150376 |
| Device Name: | Sonoma Cancellous Bone Screw And Washer |
| Classification | Screw, Fixation, Bone |
| Applicant | Sonoma Orthopedics Products, Inc 3589 Westwind Blvd Santa Rosa, CA 95403 |
| Contact | Rick Epstein |
| Correspondent | Dawn Norman Memphis Regulatory Consulting, LLC 3416 Roxee Run Cove Bartlett, TN 38133 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-13 |
| Decision Date | 2015-06-12 |
| Summary: | summary |