WAVEON WRX BONE FIXATION SYSTEM— 510(k) K090304
Substantially EquivalentSonoma Orthopedic Products, Inc.
FDA 510(k) clearance K090304 for WAVEON WRX BONE FIXATION SYSTEM, Substantially Equivalent on 2009-08-28. Applicant: Sonoma Orthopedic Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Sonoma Orthopedic Products, Inc.
- Product code
- Code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Rosa, CA, US
Recent devices under product code HRS
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- K100112 — SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM)
- K092110 — WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX)
Adverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.