Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Flap Fixator, Burr Hole Cover

K-Number: K192310 · 2020-06-03

ApplicantOssaware Biotech Co., Ltd.
Decision Date2020-06-03
Product CodeGXR
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Flap Fixator, Burr Hole Cover is the device name listed in this FDA 510(k) record. The listed applicant is Ossaware Biotech Co., Ltd.. It received FDA 510(k) clearance on 2020-06-03 under 510(k) number K192310. 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 Flap Fixator, Burr Hole Cover?

Flap Fixator, Burr Hole Cover is a medical device that received FDA 510(k) clearance on 2020-06-03. The listed applicant is Ossaware Biotech Co., Ltd.. The 510(k) number is K192310.

When did Flap Fixator, Burr Hole Cover receive FDA 510(k) clearance?

Flap Fixator, Burr Hole Cover received FDA 510(k) clearance on 2020-06-03, under 510(k) number K192310.

Who is the listed applicant for Flap Fixator, Burr Hole Cover?

The FDA 510(k) record lists Ossaware Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flap Fixator, Burr Hole Cover?

The FDA product code for Flap Fixator, Burr Hole Cover is GXR.

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.K192162NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC PlateNeurovention, LLCK181539OSSDSIGN CranioplugOssdsign ABK181382GuardianTM 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.

↑