K232607
- 510(k) number
- K232607
- Device name
- 4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM
- Applicant
- Solco Biomedical Copany India Private Limited IN
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2024-02-27
- Date received
- 2023-08-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K232607.pdf
Official FDA record: K232607
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.