DeviceClearance

Product code NKB— Orthopedic

CD HORIZON SPINAL SYSTEM

Classification name
Thoracolumbosacral Pedicle Screw System
Device class
Class 2
Regulation
21 CFR 888.3070
Advisory panel
Orthopedic
Total cleared
905
First cleared
Most recent

FDA classification definition

“Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.”

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

Market context for product code NKB

FDA has cleared 905 devices under product code NKB between 2003 and 2026, filed by 275 applicant companies. 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.

Clearances per year

last 15 years

Top applicants under product code NKB

Adverse events under product code NKB

product code NKB
Death
27
Injury
5,033
Malfunction
4,140
Total
9,200

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

Recent clearances under product code NKB

1–100 of 905

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