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FDA PRODUCT CODE · CLASS II

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 888.3080
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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