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FDA 510(k)

OSSDSIGN Cranioplug

K-Number: K181539 · 2018-10-12

ApplicantOssdsign AB
Decision Date2018-10-12
Product CodeGXR
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OSSDSIGN Cranioplug is the device name listed in this FDA 510(k) record. The listed applicant is Ossdsign AB. It received FDA 510(k) clearance on 2018-10-12 under 510(k) number K181539. The device is classified under product code GXR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSSDSIGN Cranioplug?

OSSDSIGN Cranioplug is a medical device that received FDA 510(k) clearance on 2018-10-12. The listed applicant is Ossdsign AB. The 510(k) number is K181539.

When did OSSDSIGN Cranioplug receive FDA 510(k) clearance?

OSSDSIGN Cranioplug received FDA 510(k) clearance on 2018-10-12, under 510(k) number K181539.

Who is the listed applicant for OSSDSIGN Cranioplug?

The FDA 510(k) record lists Ossdsign AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSSDSIGN Cranioplug?

The FDA product code for OSSDSIGN Cranioplug is GXR.

Other records listing Ossdsign AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232315Catalyst Bone Void FillerK212414OSSDSIGN Cranial PSIK190523Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant TrialK161090Cranial PSI

Related Devices (Code: GXR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc.K240137Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation SystemNeos Surgery S.LK221606Absorbable Cranial Flap Fixation SystemChendu Medart Medical Scientific Co., Ltd.K192310Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd.K192162NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateNeurovention, LLCK181382GuardianTM Burr Hole Cover SystemSt Jude Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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