Medical Device Manufacturer · FR , Beaurains

Clariance, Sas - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2016

Recent clearances: Idys LLIF 3DTi, Erisma LP Navigated Instruments, Idys ALIF ZP 3DTi

11
Total
11
Cleared
0
Denied

FDA 510(k) Regulatory Record - Clariance, Sas Orthopedic ✕

11 devices
1-11 of 11
Cleared Apr 01, 2021
Idys LLIF 3DTi
K202032 · OVD
Orthopedic · 253d
Cleared Feb 26, 2021
Erisma LP Navigated Instruments
K202956 · OLO
Orthopedic · 149d
Cleared May 29, 2020
Idys ALIF ZP 3DTi
K200920 · MAX
Orthopedic · 53d
Cleared Nov 04, 2019
Idys ALIF ZP 3DTi
K192168 · OVD
Orthopedic · 87d
Cleared Jun 06, 2019
Idys ALIF TiVac
K191263 · OVD
Orthopedic · 27d
Cleared Mar 01, 2019
Idys™ TLIF TiVac
K183259 · MAX
Orthopedic · 100d
Cleared Dec 15, 2017
Idys™ TLIF 3DTi Cages
K172465 · MAX
Orthopedic · 123d
Cleared Nov 08, 2017
Idys™ ALIF System
K172083 · OVD
Orthopedic · 121d
Cleared Feb 14, 2017
Erisma® LP Spinal Fixation System
K170163 · NKB
Orthopedic · 27d
Cleared Oct 27, 2016
Erisma® LP MIS
K162367 · NKB
Orthopedic · 65d
Cleared Mar 08, 2016
Erisma-LP Spinal Fixation System
K153326 · NKB
Orthopedic · 110d
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