510(k) K191423
K191423 is an FDA 510(k) premarket notification submitted by Zavation Medical Products, LLC for the device "Normandy VBR System". The FDA issued a decision of Substantially Equivalent on August 6, 2019. The device falls under product code PLR (Spinal Vertebral Body Replacement Device - Cervical), a Class II device regulated under 21 CFR 888.3060. Zavation Medical Products, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 6, 2019
- Date Received
- May 29, 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.