FDA.reportPublic FDA data

CirFIX® Cranial bone fixation system: Burr Hole Cover

Primary DI
04717002404328
Brand
CirFIX® Cranial bone fixation system: Burr Hole Cover
Company
OSSAWARE BIOTECH CO., LTD.
Model
9905.0014.11S
Catalog number
9905.0014.11S
Device description
CUSMED CirFIX® Burr Hole Cover, Radiolucent Revisable Type+Screwdriver, PEEK, 14mm/11mm, Sterile
Published
2020-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXRCover, Burr Hole

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXRCover, Burr HoleNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192310000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192310000Flap Fixator, Burr Hole CoverOssaware Biotech Co., Ltd.2020-06-03GXR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14717002404325PackageGS112In Commercial Distribution
24717002404322PackageGS148In Commercial Distribution
04717002404328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471700240432514717002404325
2471700240432224717002404322
04717002404328047170024043284717002404328

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate, non-bioabsorbable, non-customizedA small, implantable, non-customized sheet of firm material designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize a fracture gap or craniotomy flap, cover a burr hole and/or position/stabilize a prosthesis. It is made of non-bioabsorbable materials (e.g., surgical steel, titanium alloy) and is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover). Instruments intended to facilitate implantation (e.g., driver), or plate fixation implants (i.e., bone screws), may be packaged with the plate.

Contacts#

Phone, Email table
PhoneEmail
+88647980819FDA@CUSMED.COM

Regulatory Flags#

DUNS number
656747172
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04717002404335CirFIX® Cranial bone fixation system: Burr Hole Cover9906.0014.11S9906.0014.11S2020-09-14
04717002404168CirFIX® Cranial bone fixation system: Flap Fixator9903.0001.15S9903.0001.15S2020-09-28
04717002404175CirFIX® Cranial bone fixation system: Flap Fixator (3 PCS)9903.0101.15S9903.0101.15S2020-09-28
04717002404380CUSMED FACE MASK9600.0000.002021-03-23
14717002404387CUSMED FACE MASK9600.0000.002021-03-23
14717002404165CirFIX® Cranial bone fixation system: Flap Fixator9903.0001.15S9903.0001.15S2020-09-28
14717002404172CirFIX® Cranial bone fixation system: Flap Fixator (3 PCS)9903.0101.15S9903.0101.15S2020-09-28
14717002404325CirFIX® Cranial bone fixation system: Burr Hole Cover9905.0014.11S9905.0014.11S2020-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806390889049Leforte Neuro System Bone PlateJeil Medical CorporationGXR2023-11-30
G28436102NuCrani Large PlateNeurovention LLCGXR2022-06-21
08806390888851Leforte Neuro System Bone PlateJeil Medical CorporationGXR2022-05-03
07613327543032DELTAStryker Leibinger GmbH & Co. KGGXR2020-12-15
08809416061542Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
08809416061559Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-14
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08809416061696Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809416061702Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809416061719Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13
08809416061726Neuro Plating SystemOSTEONIC CO.,Ltd.GXR2019-02-13