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PJNClass II

Filler, Bone Void, Non-Alterable Compound For Cranioplasty

21 CFR 882.5330 / Neurology
FDA source (opens on fda.gov)

PJN is the FDA product code for Filler, Bone Void, Non-Alterable Compound For Cranioplasty, a class II device type, regulated under 21 CFR 882.5330. FDA's definition for this code reads: "A nonalterable cranial bone void filler is a device that is created from patient-specific computerized tomography (CT) imaging data and intended to fill 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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PJN
Device name
Filler, Bone Void, Non-Alterable Compound For Cranioplasty
FDA definition
A nonalterable cranial bone void filler is a device that is created from patient-specific computerized tomography (CT) imaging data and intended to fill 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 materials used (e.g., metals, polyether ether ketone (PEEK), etc.) in the construction of the nonalterable cranial bone void fillers are not resorbable and cannot be altered or reshaped at the time of surgery or after implantation without changing the chemical behavior of the material.
Regulation
21 CFR 882.5330
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
2
Ingested recalls
0

Clearances, product code PJN

By decision year
2 clearances under product code PJN with a decision year between 2019 and 2021, 2019 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PJN by decision year
YearClearances
20191
20211

Applicants with the most clearances

Product code PJN
Applicants holding the most 510(k) clearances under product code PJN
ApplicantClearances
Ossdsign2

Companies listing this code with FDA

Companies whose registered establishments list this code