K233960
- 510(k) number
- K233960
- Device name
- INNOVERSE Spinal System
- Applicant
- Innosys Co., Ltd. KR
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2024-02-06
- Date received
- 2023-12-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K233960.pdf
Official FDA record: K233960
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.