510(k) K221542
K221542 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 Jan 13, 2023. 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 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 13, 2023
- Date Received
- May 27, 2022
- 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
- 510(k)
Vertebral body replacement in the cervical spine.