# Sonoma Orthopedic Products, Inc.

- Location (FDA's records): Santa Rosa, CA
- FDA decisions: 9 (2008–2017): 9 510(k) clearances
- Product codes: HSB (6), HRS (2), HWC (1)
- Predicates its devices cite: 13 (3 its own); citations of its devices by later devices: 8 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Depuy, Inc.: 3 (https://510kreport.com/company/depuy)
- Wrightmedicaltechnologyinc: 2 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Acumed, LLC: 2 (https://510kreport.com/company/acumed)
- Plus Orthopedics: 1 (https://510kreport.com/company/plus-orthopedics)
- Deo Volente Orthopaedics, LLC: 1 (https://510kreport.com/company/deo-volente-orthopaedics)
- Syntec Scientific Corp.: 1 (https://510kreport.com/company/syntec-scientific)

## Firms that cite its devices most
- Intrafuse, LLC: 3 (https://510kreport.com/company/intrafuse)
- Conventus Orthopaedics, Inc.: 1 (https://510kreport.com/company/conventus-orthopaedics)
- Sonoma Orthopedics Products, Inc.: 1 (https://510kreport.com/company/sonoma-orthopedics-products)

## Its most-cited devices
- K081832: Ensplintcmx Clavicle Pin (2008), cited by 3
- K071809: Ensplintrx Bone Fixation System (2008), cited by 2
- K142945: Sonoma Fibula Repair System (2015), cited by 2
- K100112: Somona CWG Clavicle Fracture Repair Device Model Sonoma CWG Xyyy (X=Dia, Yyy=Length-in MM) (2010), cited by 1

## Recent decisions
- K161371: Sonoma Fifth Metatarsal Repair System (Feb 24, 2017)
- K142945: Sonoma Fibula Repair System (Jan 22, 2015)
- K111550: Sonoma Fastrac Clavicle Fracture Repair Device Model Sonoma Fastrac Xxyyy (X=Dia, Yyy=Length- in MM) (Aug 19, 2011)
- K100112: Somona CWG Clavicle Fracture Repair Device Model Sonoma CWG Xyyy (X=Dia, Yyy=Length-in MM) (Sep 28, 2010)
- K092110: Waveon Fracture Repair System (Waveon RX) (Jan 20, 2010)
- K090304: Waveon WRX Bone Fixation System (Aug 28, 2009)
- K081832: Ensplintcmx Clavicle Pin (Oct 10, 2008)
- K080778: Ensplint TM Bone Screw (Jul 10, 2008)

Source page: https://510kreport.com/company/sonoma-orthopedic-products