DeviceClearance

Product code PHM— Orthopedic

ATEC Universal Spacer System

Classification name
Intervertebral Fusion Device With Bone Graft, Thoracic
Device class
Class 2
Regulation
21 CFR 888.3080
Advisory panel
Orthopedic
Total cleared
3
First cleared
Most recent

FDA classification definition

“Intended to stabilize thoracic spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.”

— U.S. Food and Drug Administration, device classification record for product code PHM under 21 CFR 888.3080, via openFDA

Market context for product code PHM

FDA has cleared 3 devices under product code PHM between 2015 and 2018, filed by 3 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 PHM

Recent clearances under product code PHM

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