FDA.reportPublic FDA data

OSSDSIGN Cranial PSI

Primary DI
17350086550112
Brand
OSSDSIGN Cranial PSI
Company
Ossdsign AB
Model
XL
Catalog number
101011
Device description
OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cranial skeleton. Each Cranial PSI is a patient-specific device specifically created for a patient’s unique anatomical requirements. Cranial PSI consists of a rigid titanium mesh that is largely covered by biocompatible ceramic tiles. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids (510(k) no. K161090)
Published
2017-05-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GXNPlate, Cranioplasty, Preformed, Non-Alterable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXNPlate, Cranioplasty, Preformed, Non-AlterableNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17350086550112PackageGS11In Commercial Distribution
07350086550115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1735008655011217350086550112
07350086550115073500865501157350086550115

GMDN Terms#

Term, Definition table
TermDefinition
Cranioplasty plate, non-alterableAn implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material [e.g., stainless steel, vitallium, titanium (Ti), plastic resins] that cannot be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
350354370
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350086550238OSSDSIGN Cranioplug14 mm, 6 fixation-points2019-06-05
07350086550245OSSDSIGN Cranioplug11 mm, 2 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

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