Cranial Implant Trial

GUDID 17350086550563

OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN Cranial PSI (K161090) parent device. They are additively manufactured from PA2200 polyamide material. Each Cranial PSI Accessory is patient-specific and corresponds to a patient’s unique anatomical requirements. Cranial PSI Accessories are intended to support implantation of the corresponding Cranial PSI parent device; both devices are designed from the same patient-specific computed tomography image data set. (510(k) no. K190523)

Ossdsign AB

Custom-made orthopaedic surgical guide, sterile Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit Custom-made organ/bone anatomy model/surgical guide kit
Primary Device ID17350086550563
NIH Device Record Key4233c996-280c-4dab-9e12-528b9f6d1771
Commercial Distribution StatusIn Commercial Distribution
Brand NameCranial Implant Trial
Version Model NumberS
Company DUNS350354370
Company NameOssdsign AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 34 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107350086550566 [Primary]
GS117350086550563 [Package]
Contains: 07350086550566
Package: box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PJNFiller, Bone Void, Non-Alterable Compound For Cranioplasty

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-30
Device Publish Date2020-01-22

On-Brand Devices [Cranial Implant Trial]

17350086550594OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN
17350086550587OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN
17350086550570OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN
17350086550563OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN

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