Duet Spinal Fixation System— 510(k) K253169

Name: FDA 510(k) clearance K253169
Creator: U.S. Food and Drug Administration
Published: 2026-02-23

Substantially Equivalent

Box Spine, LLC

FDA 510(k) clearance K253169 for Duet Spinal Fixation System, Substantially Equivalent on 2026-02-23. Applicant: Box Spine, LLC. Device class: 2.

Summary

Box Spine's Duet Spinal Fixation System is filed under product code NKB, thoracolumbosacral pedicle screw system. The record doesn't describe the system beyond its name and that code name.

Class II, 21 CFR 888.3070. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).

Box Spine filed from Tulsa, Oklahoma. FDA found it substantially equivalent 150 calendar days after receipt (September 26, 2025 to February 23, 2026).

Clearance details

Applicant: Box Spine, LLC
Product code: Product code NKB
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2025-09-26
Decision date: 2026-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tulsa, OK, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NKB

view all

K262731 — Virata Spinal Fixation System2026-10-29
K261217 — AnyPlus II Spinal Fixation System2026-10-02
K263062 — NOVIX Pedicle Screw System2026-10-01
K262712 — Duet Spinal Fixation System2026-09-30
K263172 — SAS MIS Pelvic Incidence Rods2026-09-30

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.