Medical Device Manufacturer · IL , Ramat Poleg

Premia Spine, Ltd. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2015

Recent clearances: ProMIS Extension Rod System, ProMIS™ Fixation System, Premia Spine XL Instruments

6
Total
6
Cleared
0
Denied

FDA 510(k) Regulatory Record - Premia Spine, Ltd. Orthopedic ✕

6 devices
1-6 of 6
Cleared Nov 21, 2023
ProMIS Extension Rod System
K232719 · NKB
Orthopedic · 77d
Cleared Jul 07, 2023
ProMIS™ Fixation System
K231844 · NKB
Orthopedic · 15d
Cleared Oct 08, 2019
Premia Spine XL Instruments
K191854 · OLO
Orthopedic · 90d
Cleared Nov 13, 2018
VersaLink™ Fixation System
K182598 · NKB
Orthopedic · 54d
Cleared Feb 02, 2017
ProMIS™ Fixation System
K170061 · NKB
Orthopedic · 27d
Cleared Jul 17, 2015
ProMIS Fixation System
K150380 · NKB
Orthopedic · 154d
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