510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PBJClass II

Cranial Distraction System

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

PBJ is the FDA product code for Cranial Distraction System, a class II device type, regulated under 21 CFR 882.5330. FDA's definition for this code reads: "A cranial distraction system is a metal device intended to establish osteodistraction and bone growth in the skull. The bone segments are attached to the plate with screws to prevent movement of the segments". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PBJ
Device name
Cranial Distraction System
FDA definition
A cranial distraction system is a metal device intended to establish osteodistraction and bone growth in the skull. The bone segments are attached to the plate with screws to prevent movement of the segments.
Regulation
21 CFR 882.5330
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
0

Clearances, product code PBJ

By decision year
6 clearances under product code PBJ with a decision year between 2012 and 2023, 2017 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code PBJ by decision year
YearClearances
20121
20131
20151
20172
20231

Applicants with the most clearances

Product code PBJ
Applicants holding the most 510(k) clearances under product code PBJ
ApplicantClearances
KLS-Martin L.P.3
Osteomed2
Synthes (USA) Products LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code