PEEK PREVAIL CERVICAL INTERBODY DEVICE— 510(k) K073285
Substantially EquivalentMedtronic Sofamor Danek USA, Inc.
FDA 510(k) clearance K073285 for PEEK PREVAIL CERVICAL INTERBODY DEVICE, Substantially Equivalent on 2008-05-15. Applicant: Medtronic Sofamor Danek USA, Inc..
Clearance details
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Product code
- Code OVE
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, 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.