Cortera Spinal Fixation System— 510(k) K241892
Substantially EquivalentXtant Medical Holdings, Inc.
FDA 510(k) clearance K241892 for Cortera Spinal Fixation System, Substantially Equivalent on 2024-08-02. Applicant: Xtant Medical Holdings, Inc..
Clearance details
- Applicant
- Xtant Medical Holdings, Inc.
- Product code
- Code NKB
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Belgrade, MT, 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.