PJM

Filler, Bone Void, Alterable Compound For Cranioplasty

Product code

PJM

Device name

Filler, Bone Void, Alterable Compound For Cranioplasty

Device class

Class 2

21 CFR

21 CFR 882.5320

Medical specialty

Neurology

Marketing pathway

510(K)

Flag

Implant

FDA classification definition

An alterable cranial bone void filler is a device intended to be a bone substitute for the replacement of bony voids, defects, and contour irregularities in non-load bearing regions of the cranial skeleton, and are not intrinsic to the stability of the bony structure. The device is constructed from a material (e.g., calcium, polymer synthetic-based, etc.) that can be reshaped or altered at the time of surgery or after implantation without changing the chemical behavior of the material.

Definition text from the FDA device classification database (U.S. federal government work, public domain).