K230116
- 510(k) number
- K230116
- Device name
- Vital Spinal Fixation System
- Applicant
- Zimvie Spine (Zimmer Biomet Spine, Inc.) CO · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2023-10-11
- Date received
- 2023-01-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K230116.pdf
Official FDA record: K230116
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.