Bone, Heterograft

NVC · Class III — High Risk (PMA approval required, life-sustaining) · Orthopedic · 21 CFR 888.3015

Classification

FDA Product Code: NVC
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: 21 CFR 888.3015
Review panel: OR
Medical specialty: Orthopedic
Submission type: 2
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

BONE HETEROGRAFT IS A DEVICE INTENDED TO BE IMPLANTED THAT IS MADE FROM MATURE (ADULT) BOVINE BONES AND USED TO REPLACE HUMAN BONE FOLLOWING SURGERY IN THE CERVICAL REGION OF THE SPINAL COLUMN.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown