SAS MIS Pelvic Incidence Rods— 510(k) K263172

Name: FDA 510(k) clearance K263172
Creator: U.S. Food and Drug Administration
Published: 2026-09-30

Substantially Equivalent

Spinal Alignment Solutions, Inc.

FDA 510(k) clearance K263172 for SAS MIS Pelvic Incidence Rods, Substantially Equivalent on 2026-09-30. Applicant: Spinal Alignment Solutions, Inc.. Device class: 2.

Clearance details

Applicant: Spinal Alignment Solutions, Inc.
Product code: Code NKB
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2026-09-10
Decision date: 2026-09-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Wilmington, NC, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.

Clearance details

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