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Endotherapy and electrosurgical devices
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Endotherapy devices
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Spinal endotherapy devices
Spinal endotherapy devices
K0103
312 devices
Subcategories
3
K010301
Spinal percutaneous plastic devices with balloon
301
devices
K010302
Minimally invasive spinal surgery instruments, single-use
10
devices
K010399
Spinal endotherapy devices - other
1
device
Devices
Carlon
Jiangsu Trauhui Medical Instrument Co., Ltd.
·
,
China
Class IIa
CE/MDD
Renova Spine Kyphoplasty Working Cannula And Bevel Tip
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDD
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
+2
authorizations
Renova Spine Balloon Catheter
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT353495
Active
Valid to Jun 2031
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
+1
authorizations
Kyphokit Balloon Catheter
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
Sanza Balloon Catheter
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT353495
Active
Valid to Jun 2031
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
Winch Kyphoplasty Balloon Catheter 11G 20mm
G-21 S.R.L.
·
,
Italy
Class IIa
CE/MDD
GUDID
on market
Aditus Fast Access System
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
Kyphokit Kirschner Guide
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
Renova Spine Balloon Catheter
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
+1
authorizations
Rti-K
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
Kyphokit Fast Access System
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
+1
authorizations
Winch Kyphoplasty Balloon Catheter 11G 15mm
G21 S.R.L.
·
,
Italy
Class IIa
CE/MDD
GUDID
on market
Cifopack Fast Access System
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDD
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
+2
authorizations
Cifopack Fast Access System
Biopsybell SRL
·
,
Italy
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Withdrawn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 Trocar Tip
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT353495
Active
Valid to Jun 2031
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
+1
authorizations
Kyphokit Classic Access System
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT353495
Active
Valid to Jun 2031
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
Kyphokit Classic Access System
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
+2
authorizations
Kyphokit Drill
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT353495
Active
Valid to Jun 2031
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
+1
authorizations
Renova Spine Balloon Catheter
Biopsybell SRL
·
,
Italy
Class IIa
CE/MDR
IT349638
Withdrawn
Valid to Feb 2030
CE/MDR
IT353495
Active
Valid to Jun 2031
+1
authorizations
Flex Drill
G-21 S.R.L.
·
,
Italy
Class IIa
CE/MDD
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