Orthopedic

NVC · Bone, Heterograft

Orthopedic · 21 CFR 888.3015 · Class 3

Overview

Product CodeNVC
Device NameBone, Heterograft
Regulation21 CFR 888.3015
Device ClassClass 3
Review PanelOrthopedic
ImplantYes

Identification

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.

Classification Rationale

Class III.

Cleared Devices (0)

No cleared devices on record.

Innolitics

Panel 1

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