Sonoma Fibula Repair System— 510(k) K142945
Substantially EquivalentSonoma Orthopedic Products, Inc.
FDA 510(k) clearance K142945 for Sonoma Fibula Repair System, Substantially Equivalent on 2015-01-22. Applicant: Sonoma Orthopedic Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Sonoma Orthopedic Products, Inc.
- Product code
- Code HSB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3020
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Rosa, CA, US
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More clearances from Sonoma Orthopedic Products, Inc.
view all- K161371 — Sonoma Fifth Metatarsal Repair System
- K111550 — SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM)
- K100112 — SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM)
- K092110 — WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX)
- K090304 — WAVEON WRX BONE FIXATION SYSTEM
Adverse events under product code HSB
product code HSB- Death
- 49
- Injury
- 12,083
- Malfunction
- 6,561
- Other
- 1
- Total
- 18,694
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.