DeviceClearance

Product code SIN— Orthopedic

IntraOp Alignment System; CONTOUR3D Bending System

Classification name
Automated Intraoperative Spinal Rod Bending System
Device class
Class 2
Regulation
21 CFR 888.3070
Advisory panel
Orthopedic
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code SIN under 21 CFR 888.3070, via openFDA

Market context for product code SIN

FDA has cleared 1 device under product code SIN, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SIN

Recent clearances under product code SIN

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