K240963
- 510(k) number
- K240963
- Device name
- Spinal System
- Applicant
- Teslake, Inc. CA · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2024-06-06
- Date received
- 2024-04-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K240963.pdf
Official FDA record: K240963
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.