NuVasive Reline Fenestrated Screws, High V+ Bone Cement— 510(k) K180498
Substantially EquivalentNu Vasive, Incorporated
FDA 510(k) clearance K180498 for NuVasive Reline Fenestrated Screws, High V+ Bone Cement, Substantially Equivalent on 2018-11-28. Applicant: Nu Vasive, Incorporated. Device class: 2.
Clearance details
- Applicant
- Nu Vasive, Incorporated
- Product code
- Code PML
- Device class
- Class 2
- Regulation
- 21 CFR 888.3027
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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More clearances from Nu Vasive, Incorporated
view allAdverse events under product code PML
product code PML- Death
- 8
- Total
- 8
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.