The following data is part of a premarket notification filed by Sonoma Orthopedic Products, Inc. with the FDA for Sonoma Fastrac Clavicle Fracture Repair Device Model Sonoma Fastrac Xxyyy(x=dia, Yyy=length- In Mm).
| Device ID | K111550 |
| 510k Number | K111550 |
| Device Name: | SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM) |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | SONOMA ORTHOPEDIC PRODUCTS, INC. 3589 WESTWIND BLVD Santa Rosa, CA 95403 |
| Contact | Charles L Nelson |
| Correspondent | Charles L Nelson SONOMA ORTHOPEDIC PRODUCTS, INC. 3589 WESTWIND BLVD Santa Rosa, CA 95403 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-03 |
| Decision Date | 2011-08-19 |
| Summary: | summary |