K231737
- 510(k) number
- K231737
- Device name
- ANAX 5.5 Spinal System
- Applicant
- Innosys Co., Ltd. KR
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2023-10-26
- Date received
- 2023-06-14
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K231737.pdf
Official FDA record: K231737
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.