FDA.reportPublic FDA data

OSSDSIGN Cranioplug

Primary DI
07350086550245
Brand
OSSDSIGN Cranioplug
Company
Ossdsign AB
Model
11 mm, 2 fixation-points
Device description
OSSDSIGN Cranioplug is an osteoconductive calcium phosphate ceramic plug reinforced with a titanium mesh plate which together provide the mechanical performance, safety and efficacy properties. The fully cured calcium phosphate ceramic fills the void in the burr hole. The osteoconductive ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is sized to match standard 11mm and 14mm burr hole perforators. (510(k) no. K181539)
Published
2019-06-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GXRCover, Burr Hole

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXRCover, Burr HoleNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17350086550242PackageGS110Not in Commercial Distribution
27350086550249PackageGS11Not in Commercial Distribution
07350086550245PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1735008655024217350086550242
2735008655024927350086550249
07350086550245073500865502457350086550245

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Outer Diameter11Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius34 Degrees Celsius
Storage Environment Temperature40 Degrees Fahrenheit93 Degrees Fahrenheit

Regulatory Flags#

DUNS number
350354370
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350086550238OSSDSIGN Cranioplug14 mm, 6 fixation-points2019-06-05
07350086550252OSSDSIGN Cranioplug11 mm, 6 fixation-points2019-06-05
07350086550221OSSDSIGN Cranioplug14 mm, 2 fixation-pointsn/a2019-06-05
07350086550115OSSDSIGN Cranial PSIXL1010112017-05-11
07350086550429Anatomical Model OriginalHalf skull2020-07-03
07350086550436Anatomical Model OriginalWhole skull2020-07-03
07350086550504Anatomical Model ModifiedHalf skull2020-07-03
07350086550511Anatomical Model ModifiedWhole skull2020-07-03
07350086550528Plastic Drawing GuideS2020-01-22
07350086550535Plastic Drawing GuideM2020-01-22
07350086550542Plastic Drawing GuideL2020-01-22
07350086550559Plastic Drawing GuideXL2020-01-22
07350086550566Cranial Implant TrialS2020-01-22
07350086550573Cranial Implant TrialM2020-01-22
07350086550580Cranial Implant TrialL2020-01-22
07350086550597Cranial Implant TrialXL2020-01-22
07350086550085OSSDSIGN Cranial PSIS2017-05-11
07350086550092OSSDSIGN Cranial PSIM1010092017-05-11
07350086550108OSSDSIGN Cranial PSIL1010102017-05-11
07350086550733OssDsign Catalyst1 cc1040102022-12-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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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