NuVasive Reline Fenestrated Screws, High V+ Bone Cement
FDA 510(k) clearance K180498 · decided 2018-11-28
Clearance details
- K-number
- K180498
- Device name
- NuVasive Reline Fenestrated Screws, High V+ Bone Cement
- Applicant
- Nu Vasive, Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2018-02-26
- Decision date
- 2018-11-28
- Days to decision
- 275 days
- Clearance type
- Traditional
- Product code
- PML
- Device class
- 2
- Regulation number
- 888.3027
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.