The following data is part of a premarket notification filed by Sonoma Orthopedic Products, Inc. with the FDA for Waveon Wrx Bone Fixation System.
| Device ID | K090304 |
| 510k Number | K090304 |
| Device Name: | WAVEON WRX BONE FIXATION SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | SONOMA ORTHOPEDIC PRODUCTS, INC. 650 LARKFIELD CENTER SUITE C Santa Rosa, CA 95403 |
| Contact | Carlos Gonzalez |
| Correspondent | Carlos Gonzalez SONOMA ORTHOPEDIC PRODUCTS, INC. 650 LARKFIELD CENTER SUITE C Santa Rosa, CA 95403 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-06 |
| Decision Date | 2009-08-28 |
| Summary: | summary |