ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS— 510(k) K110895
Substantially EquivalentOrtho Solutions Limited
FDA 510(k) clearance K110895 for ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS, Substantially Equivalent on 2011-12-19. Applicant: Ortho Solutions Limited. Device class: 2.
Clearance details
- Applicant
- Ortho Solutions Limited
- Product code
- Code HWC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Prior Lake, MN, US
Recent devices under product code HWC
view allMore clearances from Ortho Solutions Limited
view allAdverse events under product code HWC
product code HWC- Death
- 20
- Injury
- 15,910
- Malfunction
- 8,192
- Other
- 1
- Total
- 24,123
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.