SIN

Automated Intraoperative Spinal Rod Bending System

Product code: SIN
Device name: Automated Intraoperative Spinal Rod Bending System
Device class: Class 2
21 CFR: 21 CFR 888.3070
Medical specialty: Orthopedic
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 1

FDA classification definition

A rod bending system is intended to be used to intraoperatively bend thoracolumbosacral pedicle screw system rods by executing bending instructions in accordance with a user-defined rod plan to generate a patient-matched rod.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-06-25.

Number	Decision date	Applicant	Device name	Summary
K253216	2026-06-25	Alphatec Spine, Inc.	IntraOp Alignment System; CONTOUR3D Bending System	PDF

1 summaries are archived here for direct download.

Official FDA classification page: SIN

Classification and pathway per current FDA publications. Data from openFDA (CC0).