Waveon Fracture Repair System (Waveon RX)
FDA 510(k) K092110 · Sonoma Orthopedic Products, Inc.
510(k) numberK092110
Submission
- Device name
- Waveon Fracture Repair System (Waveon RX)
- Applicant
- Sonoma Orthopedic Products, Inc.
Santa Rosa, CA, US - Received
- July 14, 2009
- Decision date
- January 20, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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More from Fusion Orthopedics USA, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K161371 | Sonoma Fifth Metatarsal Repair SystemHSB · Traditional | 02/24/2017SE |
| K142945 | Sonoma Fibula Repair SystemHSB · Traditional | 01/22/2015SE |
| K111550 | Sonoma Fastrac Clavicle Fracture Repair Device Model Sonoma Fastrac Xxyyy(X=Dia…HSB · Traditional | 08/19/2011SE |
| K100112 | Somona CWG Clavicle Fracture Repair Device Model Sonoma CWG Xyyy(X=Dia, Yyy=Length-In MM)HSB · Traditional | 09/28/2010SE |
| K090304 | Waveon WRX Bone Fixation SystemHRS · Traditional | 08/28/2009SE |
| K081832 | Ensplintcmx Clavicle PinHSB · Traditional | 10/10/2008SE |
| K080778 | Ensplint TM Bone ScrewHWC · Traditional | 07/10/2008SE |
| K071809 | Ensplintrx Bone Fixation SystemHRS · Traditional | 02/21/2008SE |
Questions and answers
When was Waveon Fracture Repair System (Waveon RX) cleared by the FDA?
Waveon Fracture Repair System (Waveon RX) (K092110) received a 510(k) decision of Substantially Equivalent on January 20, 2010, 190 days after the submission was received.
What is the product code of K092110?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.