Cleared Traditional

CranioXpand

K230211 · KLS-Martin L.P. · Neurology

Nov 2023

Decision

299d

Days

Class 2

Risk

About This 510(k) Submission

K230211 is an FDA 510(k) clearance for the CranioXpand, a Cranial Distraction System (Class II — Special Controls, product code PBJ), submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on November 21, 2023, 299 days after receiving the submission on January 26, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5330.

Submission Details

510(k) Number	K230211 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 26, 2023
Decision Date	November 21, 2023
Days to Decision	299 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	PBJ — Cranial Distraction System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5330
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.