Ossdsign AB is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
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
Ossdsign AB has 6 FDA 510(k) cleared medical devices. Based in Madison, US.
Last cleared in 2023. Active since 2014. Primary specialty: Neurology.
Browse the FDA 510(k) cleared devices submitted by Ossdsign AB Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Weissburg Associates and David Weissburg.
FDA 510(k) Regulatory Record - Ossdsign AB
6 devices
Cleared
Sep 15, 2023
Catalyst Bone Void Filler
Orthopedic
44d
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