PHM — Intervertebral Fusion Device With Bone Graft, Thoracic Class II
FDA product code PHM covers "Intervertebral Fusion Device With Bone Graft, Thoracic", a Class II medical device regulated under 21 CFR 888.3080. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PHM
- Device Class
- Class II
- Regulation Number
- 888.3080
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
Intended to stabilize thoracic spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.