510(k) K183071
K183071 is an FDA 510(k) premarket notification submitted by Stryker Spine for the device "VLIFT-s Vertebral Body Replacement System". The FDA issued a decision of Substantially Equivalent on January 10, 2019. The device falls under product code PLR (Spinal Vertebral Body Replacement Device - Cervical), a Class II device regulated under 21 CFR 888.3060. Stryker Spine has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 10, 2019
- Date Received
- November 5, 2018
- Clearance Type
- Special
- 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.