Sonoma Orthopedic Products, Inc.
Sonoma Orthopedic Products, Inc. has 0 FDA recalls, 3 inspections, 9 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Sep 15, 2016 · NAI
- Latest 510(k)
- Feb 24, 2017
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 9 | Oct 4, 2026 | Not stated | Current |
| Inspections | 3 | Oct 26, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Sep 15, 2016 | Buffalo Grove, IL | Devices | No Action Indicated (NAI) | 3007038372 |
| Feb 13, 2013 | Buffalo Grove, IL | Devices | No Action Indicated (NAI) | 3007038372 |
| Nov 8, 2010 | Buffalo Grove, IL | Devices | No Action Indicated (NAI) | 3007038372 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| 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 |
| K071809 | ENSPLINTRX BONE FIXATION SYSTEM | Feb 21, 2008 |