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PJMClass II

Filler, Bone Void, Alterable Compound For Cranioplasty

21 CFR 882.5320 / Neurology
FDA source (opens on fda.gov)

PJM is the FDA product code for Filler, Bone Void, Alterable Compound For Cranioplasty, a class II device type, regulated under 21 CFR 882.5320. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PJM
Device name
Filler, Bone Void, Alterable Compound For Cranioplasty
FDA 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.
Regulation
21 CFR 882.5320
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code PJM.