510(k) clearance
iFuse Granite Onyx™ Implant System
- 510(k) number
- K262067
- Applicant
- SI-BONE, Inc.
- Decision date
- Sep 23, 2026
- Date received
- Jun 22, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- NKB
- Device type
- Thoracolumbosacral Pedicle Screw System
- Device class
- Class II
- Regulation
- 21 CFR 888.3070
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Santa Clara, CA, US