FDA.reportPublic FDA data

OSSDSIGN Cranial PSI

Primary DI
07350086550108
Brand
OSSDSIGN Cranial PSI
Company
Ossdsign AB
Model
L
Catalog number
101010
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
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
17350086550105PackageGS11In Commercial Distribution
07350086550108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1735008655010517350086550105
07350086550108073500865501087350086550108

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
Premarket exempt
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350086550733OssDsign Catalyst1 cc1040102022-12-08
07350086550702OssDsign Catalyst10cc1041002021-08-10
07350086550719OssDsign Catalyst5cc1040502021-08-10
07350086550726OssDsign Catalyst2.5cc2021-08-10
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

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