4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM— 510(k) K102458
Substantially EquivalentSolco Biomedical Co., Ltd.
FDA 510(k) clearance K102458 for 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM, Substantially Equivalent on 2011-06-13. Applicant: Solco Biomedical Co., Ltd..
Clearance details
- Applicant
- Solco Biomedical Co., Ltd.
- Product code
- Code MNH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rockville, MD, US
Adverse events under product code MNH
product code MNH- Injury
- 978
- Malfunction
- 793
- Total
- 1,771
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.