510(k) K192145
K192145 is an FDA 510(k) premarket notification submitted by Bright Spine for the device "Galileo Vertebral Body Replacement Device". The FDA issued a decision of Substantially Equivalent on April 21, 2020. The device falls under product code PLR (Spinal Vertebral Body Replacement Device - Cervical), a Class II device regulated under 21 CFR 888.3060. Bright Spine has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 2020
- Date Received
- August 8, 2019
- 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.