Premia Spine, Ltd. - FDA 510(k) Cleared Devices
6
Total
6
Cleared
0
Denied
FDA 510(k) cleared devices by Premia Spine, Ltd. Orthopedic ✕
6 devices
Cleared
Nov 21, 2023
ProMIS Extension Rod System
Orthopedic
77d
Cleared
Jul 07, 2023
ProMIS™ Fixation System
Orthopedic
15d
Cleared
Oct 08, 2019
Premia Spine XL Instruments
Orthopedic
90d
Cleared
Nov 13, 2018
VersaLink™ Fixation System
Orthopedic
54d
Cleared
Feb 02, 2017
ProMIS™ Fixation System
Orthopedic
27d
Cleared
Jul 17, 2015
ProMIS Fixation System
Orthopedic
154d