Spinal Alignment Solutions Pelvic Incidence (PI) Rod System— 510(k) K242350
Substantially EquivalentSpinal Alignment Solutions, Inc.
FDA 510(k) clearance K242350 for Spinal Alignment Solutions Pelvic Incidence (PI) Rod System, Substantially Equivalent on 2024-10-28. Applicant: Spinal Alignment Solutions, Inc..
Clearance details
- Applicant
- Spinal Alignment Solutions, Inc.
- Product code
- Code NKB
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tiverton, RI, US
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.