MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate— 510(k) K182151
Substantially EquivalentCtl Medical Corporation
FDA 510(k) clearance K182151 for MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate, Substantially Equivalent on 2018-10-11. Applicant: Ctl Medical Corporation.
Clearance details
- Applicant
- Ctl Medical Corporation
- Product code
- Code OVE
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Addison, TX, US
Adverse events under product code OVE
product code OVE- Injury
- 293
- Malfunction
- 710
- Total
- 1,003
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.