Cleared Traditional

K140309 - CRANIOPLUG

K140309 is an FDA 510(k) clearance for CRANIOPLUG, manufactured by Ossdsign AB. The device is a Class 2 Neurology device with product code GXR cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K140309 · Ossdsign AB · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
238d
Days
Class 2
Risk

K140309 is an FDA 510(k) clearance for the CRANIOPLUG. Classified as Cover, Burr Hole (product code GXR), Class II - Special Controls.

Submitted by Ossdsign AB (Madison, US). The FDA issued a Cleared decision on October 3, 2014 after a review of 238 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5250 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ossdsign AB devices

FDA 510(k) Submission Details - K140309

510(k) Number K140309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2014
Decision Date October 03, 2014
Days to Decision 238 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 148d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXR Device Classification - Class 2, Special Controls

Product Code GXR Cover, Burr Hole
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GXR Cover, Burr Hole

All 17
Devices cleared under the same product code (GXR) and FDA review panel - the closest regulatory comparables to K140309.
OSSDSIGN Cranioplug
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GuardianTM Burr Hole Cover System
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K152342 · St Jude Medical · Jun 2016
RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM
K130309 · Biomet Microfixation · Jun 2013
AESCULAP PEEK CRANIOFIX
K091692 · Aesculap, Inc. · Aug 2010
MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM
K042986 · Synthes (Usa) · Nov 2004