K240233
- 510(k) number
- K240233
- Device name
- Pitkar Spinal Pedicle Screw System
- Applicant
- S.H.Pitkar Orthotools Pvt. , Ltd. IN
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2024-09-09
- Date received
- 2024-01-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K240233.pdf
Official FDA record: K240233
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.