Cranioplug

FDA 510(k) K140309 · Ossdsign AB

Substantially Equivalent

510(k) numberK140309

Submission

Device name
Cranioplug
Applicant
Ossdsign AB
Madison, WI, US
Received
February 7, 2014
Decision date
October 3, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GXR – Cover, Burr Hole
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5250
Specialty
Neurology
Implant
Yes

Other 510(k)s with product code GXR

510(k)DeviceApplicantDecision
K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)GXR · Traditional Orthocon, Inc.03/16/2026SE
K240137Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemGXR · Special Neos Surgery S.L02/16/2024SE
K221606Absorbable Cranial Flap Fixation SystemGXR · Traditional Chendu Medart Medical Scientific Co., Ltd.11/21/2023SE
K192310Flap Fixator, Burr Hole CoverGXR · Traditional Ossaware Biotech Co., Ltd.06/03/2020SE
K192162NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateGXR · Traditional Neurovention, LLC03/13/2020SE
K181539OSSDSIGN CranioplugGXR · Traditional Ossdsign AB10/12/2018SE
K181382GuardianTM Burr Hole Cover SystemGXR · Abbreviated St Jude Medical07/20/2018SE
K160739Cranial COVERGXR · Traditional Neos Surgery S.L06/12/2016SE
K152342Guardian Burr Hole Cover System, Guardian Screw, Burr Hole CoverGXR · Traditional St Jude Medical06/09/2016SE
K141368Neuropace Burr Hole CoverGXR · Special NeuroPace, Inc.07/11/2014SE

More from NeuroPace, Inc.

510(k)DeviceDecision
K232315Catalyst Bone Void FillerMQV · Traditional 09/15/2023SE
K212414OSSDSIGN Cranial PSIPJN · Traditional 10/01/2021SE
K190523Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical…PJN · Traditional 10/10/2019SE
K181539OSSDSIGN CranioplugGXR · Traditional 10/12/2018SE
K161090Cranial PSIGXN · Traditional 01/19/2017SE

Questions and answers

When was Cranioplug cleared by the FDA?

Cranioplug (K140309) received a 510(k) decision of Substantially Equivalent on October 3, 2014, 238 days after the submission was received.

What is the product code of K140309?

The FDA product code is GXR – Cover, Burr Hole, a Class II (moderate risk) device regulated under 21 CFR 882.5250.