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Endotherapy and electrosurgical devices
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Endotherapy devices
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Spinal endotherapy devices
/
Spinal percutaneous plastic devices with balloon
Spinal percutaneous plastic devices with balloon
K010301
301 devices
Devices
Aditus Balloon Catheter
Biopsybell SRL
·
,
IT
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
Rti-K
Biopsybell SRL
·
,
IT
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
Kyphokit Working Cannula And Bevel Tip
Biopsybell SRL
·
,
IT
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
+1
authorizations
Renova Spine Balloon Catheter
Biopsybell SRL
·
,
IT
Class IIa
CE/MDR
IT353495
Active
Valid to Jun 2031
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
+1
authorizations
Renova Spine Kyphoplasty Drill
Biopsybell SRL
·
,
IT
Class IIa
CE/MDR
IT353495
Active
Valid to Jun 2031
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
Renova Spine Kyphoplasty Bone Access Needle
Biopsybell SRL
·
,
IT
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
Aditus Kyphoplasty Kirschner Guide
Biopsybell SRL
·
,
IT
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
Aditus Fast Access System
Biopsybell SRL
·
,
IT
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
Renova Spine Balloon Catheter
Biopsybell SRL
·
,
IT
Class IIa
CE/MDR
IT353495
Active
Valid to Jun 2031
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
+2
authorizations
Osteopearl
Biopsybell SRL
·
,
IT
Class IIa
CE/MDD
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
+2
authorizations
Kyphokit Balloon Catheter
Biopsybell SRL
·
,
IT
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
+1
authorizations
Kyphokit Fast Access System
Biopsybell SRL
·
,
IT
Class IIa
CE/MDR
IT353495
Active
Valid to Jun 2031
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
+1
authorizations
Kyphotray Balloon Catheter
Biopsybell SRL
·
,
IT
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
Aditus Kyphoplasty Bone Access Needle
Biopsybell SRL
·
,
IT
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
Aditus Classic Access System
Biopsybell SRL
·
,
IT
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
Renova Spine Working Cannula And Bevel Tip
Biopsybell SRL
·
,
IT
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
Aditus Fast Access System
Biopsybell SRL
·
,
IT
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
+1
authorizations
Renova Spine Kyphoplasty Working Cannula And Bevel/Trocar Tip
Biopsybell SRL
·
,
IT
Class IIa
CE/MDD
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
+1
authorizations
Kyphoset Balloon Catheter
Biopsybell SRL
·
,
IT
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
+1
authorizations
Renova Spine Kyphoplasty Drill
Biopsybell SRL
·
,
IT
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
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