510(k) clearance
SAS MIS Pelvic Incidence Rods
- 510(k) number
- K263172
- Applicant
- Spinal Alignment Solutions, Inc.
- Decision date
- Sep 30, 2026
- Date received
- Sep 10, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- 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
- Wilmington, NC, US