Anatomical Model Original

GUDID 17350086550426

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 organ/bone anatomy model

• Primary Device ID: 17350086550426
• NIH Device Record Key: be1a907e-c997-4937-a60e-b68dbb8d056a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anatomical Model Original
• Version Model Number: Half skull
• Company DUNS: 350354370
• Company Name: Ossdsign AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 34 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350086550429 [Primary]
GS1	17350086550426 [Package]; Contains: 07350086550429; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190523

FDA Product Code

• PJN: Filler, Bone Void, Non-Alterable Compound For Cranioplasty

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-13
• Device Publish Date: 2020-07-03

On-Brand Devices [Anatomical Model Original]

• 17350086550631: OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN
• 17350086550624: OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN
• 17350086550617: OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN
• 17350086550600: OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN
• 17350086550433: OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN
• 17350086550426: OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN