4CIS SARA Spine System, 4CIS VERTU Spine System— 510(k) K202498
Substantially EquivalentSolco Biomedical Company India Private Limited
FDA 510(k) clearance K202498 for 4CIS SARA Spine System, 4CIS VERTU Spine System, Substantially Equivalent on 2021-02-18. Applicant: Solco Biomedical Company India Private Limited.
Clearance details
- Applicant
- Solco Biomedical Company India Private Limited
- Product code
- Code NKB
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Village-Rajpur, IN
Adverse events under product code NKB
product code NKB- Death
- 27
- Injury
- 5,033
- Malfunction
- 4,140
- Total
- 9,200
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.