K240350
- 510(k) number
- K240350
- Device name
- AnyPlus II Spinal Fixation System
- Applicant
- GS Medical Co., Ltd. KR
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2024-04-03
- Date received
- 2024-02-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K240350.pdf
Official FDA record: K240350
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.