Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial

Filler, Bone Void, Non-alterable Compound For Cranioplasty

OssDsign AB

The following data is part of a premarket notification filed by Ossdsign Ab with the FDA for Cranial Psi Accessory – Anatomical Model Original, Cranial Psi Accessory – Anatomical Model Modified, Cranial Psi Accessory – Plastic Drawing Guide, Cranial Psi Accessory – Cranial Implant Trial.

Pre-market Notification Details

• Device ID: K190523
• 510k Number: K190523
• Device Name: Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial
• Classification: Filler, Bone Void, Non-alterable Compound For Cranioplasty
• Applicant: OssDsign AB Virdings Alle 2 Uppsala, SE Se 754 50
• Contact: Ulrik Birgersson
• Correspondent: David Weissburg; Weissburg Associates 300 2nd Avenue SE, #14 St. Petersburg, FL 33701
• Product Code: PJN
• CFR Regulation Number: 882.5330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-03-04
• Decision Date: 2019-10-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
17350086550679	K190523	000
17350086550563	K190523	000
17350086550556	K190523	000
17350086550549	K190523	000
17350086550532	K190523	000
17350086550525	K190523	000
17350086550518	K190523	000
17350086550501	K190523	000
17350086550433	K190523	000
17350086550570	K190523	000
17350086550587	K190523	000
17350086550662	K190523	000
17350086550655	K190523	000
17350086550648	K190523	000
17350086550631	K190523	000
17350086550624	K190523	000
17350086550617	K190523	000
17350086550600	K190523	000
17350086550594	K190523	000
17350086550426	K190523	000