510(k) K180550
K180550 is an FDA 510(k) premarket notification submitted by Nu Vasive, Incorporated for the device "NuVasive Monolith Cervical Corpectomy System". The FDA issued a decision of Substantially Equivalent on November 20, 2018. The device falls under product code PLR (Spinal Vertebral Body Replacement Device - Cervical), a Class II device regulated under 21 CFR 888.3060. Nu Vasive, Incorporated has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 20, 2018
- Date Received
- March 1, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spinal Vertebral Body Replacement Device - Cervical
- Device Class
- Class II
- Regulation Number
- 888.3060
- Review Panel
- OR
- Submission Type
Vertebral body replacement in the cervical spine.