ACURA Stabilization System— 510(k) K200937
Substantially EquivalentIndius Medical Technologies Pvt. , Ltd.
FDA 510(k) clearance K200937 for ACURA Stabilization System, Substantially Equivalent on 2020-10-26. Applicant: Indius Medical Technologies Pvt. , Ltd..
Clearance details
- Applicant
- Indius Medical Technologies Pvt. , Ltd.
- Product code
- Code NKB
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pune, 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.