K230325
- 510(k) number
- K230325
- Device name
- GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System
- Applicant
- Greens Surgicals Pvt. , Ltd. IN
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2024-10-10
- Date received
- 2023-02-06
- 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: K230325.pdf
Official FDA record: K230325
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.