FDA.reportPublic FDA data

CirFIX® Cranial bone fixation system: Flap Fixator

Primary DI
04717002404168
Brand
CirFIX® Cranial bone fixation system: Flap Fixator
Company
OSSAWARE BIOTECH CO., LTD.
Model
9903.0001.15S
Catalog number
9903.0001.15S
Device description
CUSMED Flap Fixator, Low Profile Replaceable Type+Screwdriver, PEEK, D15mm, 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
14717002404165PackageGS18Not in Commercial Distribution
14717002404653PackageGS112In Commercial Distribution
24717002404162PackageGS132Not in Commercial Distribution
24717002404650PackageGS160In Commercial Distribution
04717002404168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471700240416514717002404165
1471700240465314717002404653
2471700240416224717002404162
2471700240465024717002404650
04717002404168047170024041684717002404168

GMDN Terms#

Term, Definition table
TermDefinition
Cranial bone flap fixation clipA sterile, non-metallic, non-bioabsorbable device designed to be partially implanted around the perimeter of a replaced cranial bone flap after a craniotomy to ensure structural stability during the healing period. It is typically made of biocompatible plastic materials [e.g., polyoxymethylene (POM), commonly known as Delrin] and is typically designed with internal and external flanges that are tensioned together over the bone of both the flap and skull and locked via a central stem. It may also be used for craniofacial bone fracture fixation. Its non-metallic design makes it more compatible with radiological imaging than metallic clips.

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
04717002404328CirFIX® Cranial bone fixation system: Burr Hole Cover9905.0014.11S9905.0014.11S2020-09-28
04717002404335CirFIX® Cranial bone fixation system: Burr Hole Cover9906.0014.11S9906.0014.11S2020-09-14
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
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