PHM · Class II · 21 CFR 888.3080

FDA Product Code PHM: Intervertebral Fusion Device With Bone Graft, Thoracic

Intended To Stabilize Thoracic Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.

Leading manufacturers include Nu Vasive, Incorporated and Alphatec Spine, Inc..

3
Total
3
Cleared
105d
Avg days
2015
Since

FDA 510(k) Cleared Intervertebral Fusion Device With Bone Graft, Thoracic Devices (Product Code PHM)

3 devices
1–3 of 3
Cleared May 31, 2018
ATEC Universal Spacer System
K180480
Alphatec Spine, Inc.
Orthopedic · 97d
Cleared Jun 17, 2015
NuVasive CoRoent Thoracolumbar Implants
K150994
Nu Vasive, Incorporated
Orthopedic · 63d

About Product Code PHM - Regulatory Context