Ossdsign AB - FDA 510(k) Cleared Devices
Recent clearances: Catalyst Bone Void Filler, OSSDSIGN Cranial PSI, Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ossdsign AB Neurology ✕
5 devices
Cleared
Oct 01, 2021
OSSDSIGN Cranial PSI
Neurology
59d
Cleared
Oct 10, 2019
Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory –...
Neurology
220d
Cleared
Oct 12, 2018
OSSDSIGN Cranioplug
Neurology
123d
Cleared
Jan 19, 2017
Cranial PSI
Neurology
276d
Cleared
Oct 03, 2014
CRANIOPLUG
Neurology
238d