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510(k) Data Aggregation
K Number
K192310Device Name
Flap Fixator, Burr Hole Cover
Manufacturer
Ossaware Biotech Co., Ltd.
Date Cleared
2020-06-03
(282 days)
Product Code
GXR
Regulation Number
882.5250Why did this record match?
Applicant Name (Manufacturer) :
Ossaware Biotech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CirFIX® Cranial Bone Fixation System: Flap Fixator is intended for use to post-craniotomy bone flap fixation and the Burr Hole Cover is to be used for covering a single burr hole.
Device Description
The CirFIX® Cranial bone fixation system: Flap Fixator is a biocompatible, postoperative cranial bone fixation system that fixes the bone flap to the skull after craniotomy and Burr Hole Cover which is for covering a single burr hole resulting from cranial surgery.
The CirFIX® Cranial bone fixation system is provided in sterile, for a single use. With available sizes for cranial thickness ranging from 3 mm to 14 mm and burr holes with an epicranial diameter from 10 to 15 mm, made by standard perforators or with spherical drills, can be covered.
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