DeviceClearance

Product code PGM— Orthopedic

CD HORIZON Growth Rod Conversion Set

Classification name
Growing Rod System
Device class
Class 2
Regulation
21 CFR 888.3070
Advisory panel
Orthopedic
Total cleared
14
First cleared
Most recent

FDA classification definition

“Stabilization or correction of spinal deformities without the use of fusion.”

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

Market context for product code PGM

FDA has cleared 14 devices under product code PGM between 2014 and 2026, filed by 13 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

Top applicants under product code PGM

Recent clearances under product code PGM

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