CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)— 510(k) K233951
Substantially EquivalentMedtronic Sofamor Danek USA, Inc.
FDA 510(k) clearance K233951 for CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw), Substantially Equivalent on 2024-03-27. Applicant: Medtronic Sofamor Danek USA, Inc..
Clearance details
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Product code
- Code NKB
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, 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.