Anatomical Model Original

Basic Information

• Brand Name: Anatomical Model Original
• Primary DI: 07350086550610
• Version / Model: M
• Company Name: Ossdsign AB
• Labeler DUNS: 350354370
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-22
• Public Version: 3
• Public Version Date: 2020-07-03
• Public Version Status: Update
• Public Device Record Key: 0f4596b7-d901-4295-9140-4e47b7316c7f
• Distribution End Date: 2020-07-03

Device Description

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)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PJN	Filler, Bone Void, Non-Alterable Compound For Cranioplasty	Neurology	882.5330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61397	Custom-made orthopaedic surgical guide, sterile	A sterile, custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is made of synthetic polymer materials and is typically manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	17350086550617	GS1	box	1	Not in Commercial Distribution	2020-07-03
Primary	07350086550610	GS1

Premarket Submissions

Submission Number	Supplement Number
K190523	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 34 Degrees Celsius