Premia Spine, Ltd. is one of 267 FDA 510(k) medical device manufacturers from Israel in the dataset, ranked by real submission volume.
Premia Spine, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: ProMIS Extension Rod System, ProMIS™ Fixation System, Premia Spine XL Instruments
6
Total
6
Cleared
0
Denied
Premia Spine, Ltd. has 6 FDA 510(k) cleared medical devices. Based in Ramat Poleg, IL.
Last cleared in 2023. Active since 2015. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Premia Spine, Ltd. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Hogan Lovells US LLP and Hogan Lovells.
FDA 510(k) Regulatory Record - Premia Spine, Ltd.
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