FDA.report

Bone access channel kit

Definition
A collection of sterile manual devices intended to create a percutaneous access channel within a vertebral body or other bones (e.g., hand, radius, tibia, calcaneus) prior to the use of an inflatable balloon (e.g., a balloon catheter or balloon tamp) to create a bone space during kyphoplasty/osteoplasty. It typically consists of bone access needles/cannulae, orthopaedic bone wires (Kirschner wires), a drill, and a curette. It is used in orthopaedic surgery, typically under fluoroscopic guidance, to treat a patient diagnosed with compression fractures. This is a single-use device.
GUDID devices
182
Last updated
2025-12-17 15:30:37

Related Product Codes

CodeDeviceSpecialtyClassDevices
LXHOrthopedic Manual Surgical InstrumentOrthopedic167
OCJSpinal Channeling Instrument, VertebroplastyOrthopedic150
NDNCement, Bone, VertebroplastyOrthopedic225
HRXArthroscopeOrthopedic220
GDFGuide, Needle, SurgicalGeneral, Plastic Surgery113
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery14
HTWBit, DrillOrthopedic14
GAHStylet, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery12
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery11
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery11
HTYPin, Fixation, SmoothOrthopedic21
HXGTampOrthopedic11
HXYBrace, DrillOrthopedic11
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)Pathology11

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
06938695502155Bone DrillShanghai Kinetic Medical Co., Ltd.FG27012025-12-09
06938695502254CannulaShanghai Kinetic Medical Co., Ltd.FG22032025-12-09
06938695521026DrillShanghai Kinetic Medical Co., Ltd.FG21002025-12-09
06938695527004Bone DrillShanghai Kinetic Medical Co., Ltd.FG27002025-12-09
50885380174184Aero-MedAERO-MED, LLCCA246752019-07-24
B90829211908Main-AXS Needle-RetropsoasMainstream Medical Devices, LLC292-11-9082025-04-30
08033860034757BIOPSYBELLBIOPSYBELL SRLRENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVEL2020-06-12
08033860034764BIOPSYBELLBIOPSYBELL SRLRENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCA2020-06-12
08033860034771BIOPSYBELLBIOPSYBELL SRLRENOVA SPINE KYPHOPLASTY DRILL2020-06-12
08033860037314BIOPSYBELL SRLBIOPSYBELL SRLRENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVEL2022-09-28
08033860043643BIOPSYBELLBIOPSYBELL SRLRENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVEL2024-02-23
08058964726476WKK Traditional AccessG21 SRL9000192025-02-26
08058964726483WKK First Access NeedleG21 SRL9000862025-02-26
08058964726490WKK Cannulated Working CannulaG21 SRL9000872025-02-26
08058964726513WKK Guide Wire, Trocar and Round Tip 17GG21 SRL9000892025-02-26
B908350008000Main-AXS Needle-Spinal SimplicityMainstream Medical Devices, LLC292-11-9202024-12-03
B908350009000Main-AXS Needle-Spinal SimplicityMainstream Medical Devices, LLC299-08-9002024-12-03
08058964724427KeyFix Bone DrillG21 SRL9001412024-10-14
08058964727718Keyfix bone drill 9GG21 SRL9002042024-10-10
08033860019174BIOPSYBELLBIOPSYBELL SRLRENOVA SPINE KYPHOPLASTY KIRSCHNER GUIDE2024-04-19
08033860044749BIOPSYBELLBIOPSYBELL SRLBONE ACCESS NEEDLE2024-04-12
08033860044763BIOPSYBELLBIOPSYBELL SRLBONE ACCESS NEEDLE2024-04-12
M97031000400010Trajectory Wire, DynaFuseMedshape, Inc.3100-04-00012024-04-01
M9702102400400.035" x 5" K-Wire StandardTrilliant Surgical, LLC210-24-0042024-03-21
08033860025632BIOPSYBELLBIOPSYBELL SRLRENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCA2024-02-23
08033860043650BIOPSYBELLBIOPSYBELL SRLRENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVEL2024-02-23
00763000311780OSTEOCOOL KIT BONE ACCESS 10G 090MEDTRONIC SOFAMOR DANEK, INC.OCN0022020-11-06
08033860019365BIOPSYBELLBIOPSYBELL SRLBONE ACCESS NEEDLE2023-08-28
08033860022310BIOPSYBELLBIOPSYBELL SRLBONE ACCESS NEEDLE2023-08-28
08033860029166BIOPSYBELLBIOPSYBELL SRLBONE ACCESS NEEDLE2023-06-26
08033860036256BIOPSYBELLBIOPSYBELL SRLBONE ACCESS NEEDLE2023-06-26
08033860037055BIOPSYBELLBIOPSYBELL SRLBONE ACCESS NEEDLE2023-06-26
08033860019167BIOPSYBELLBIOPSYBELL SRLRENOVA SPINE KYPHOPLASTY KIRSCHNER GUIDE2023-06-19
08033860025922BIOPSYBELLBIOPSYBELL SRLKYPHOKIT KIRSCHNER GUIDE2023-06-19
08033860035877BIOPSYBELLBIOPSYBELL SRLCIFOPACK KIRSCHNER GUIDE2023-06-19
08033860018825BIOPSYBELLBIOPSYBELL SRLRENOVA SPINE CLASSIC ACCESS SYSTEM2023-06-16
08033860018917BIOPSYBELLBIOPSYBELL SRLRENOVA SPINE KYPHOPLASTY BONE ACCESS NEEDLE2023-06-16
08033860018931BIOPSYBELLBIOPSYBELL SRLRENOVA SPINE KYPHOPLASTY WORKING CANNULA AND EXPAN2023-06-16
08033860019013BIOPSYBELLBIOPSYBELL SRLRENOVA SPINE FAST ACCESS SYSTEM2023-06-16
08033860023041BIOPSYBELLBIOPSYBELL SRLKYPHOKIT WORKING CANNULA AND BEVEL TIP2023-06-16
08033860023058BIOPSYBELLBIOPSYBELL SRLKYPHOKIT WORKING CANNULA AND TROCAR TIP2023-06-16
08033860025915BIOPSYBELLBIOPSYBELL SRLKYPHOKIT BONE ACCESS NEEDLE2023-06-16
08033860025946BIOPSYBELLBIOPSYBELL SRLKYPHOKIT WORKING CANNULA AND EXPANDER2023-06-16
08033860035181BIOPSYBELLBIOPSYBELL SRLKYPHOKIT CLASSIC ACCESS SYSTEM2023-06-16
08033860036713BIOPSYBELLBIOPSYBELL SRLKYPHOKIT FAST ACCESS SYSTEM2023-06-16
08033860038830BIOPSYBELLBIOPSYBELL SRLKYPHOKIT WORKING CANNULA AND BEVEL/TROCAR TIP2023-06-16
08033860041694BIOPSYBELLBIOPSYBELL SRLKYPHOKIT WORKING CANNULA AND DIAMOND TIP2023-06-16
08033860034900BIOPSYBELL SRLBIOPSYBELL SRLCIFOPACK WORKING CANNULA AND BEVEL/TROCAR TIP2023-06-15
08033860035860BIOPSYBELLBIOPSYBELL SRLCIFOPACK BONE ACCESS NEEDLE2023-06-15
08033860035907BIOPSYBELLBIOPSYBELL SRLCIFOPACK CLASSIC ACCESS SYSTEM2023-06-15
08033860036850BIOPSYBELLBIOPSYBELL SRLCIFOPACK FAST ACCESS SYSTEM2023-06-15
08033860036942BIOPSYBELLBIOPSYBELL SRLCIFOPACK WORKING CANNULA AND BEVEL TIP2023-06-15
08033860040307BIOPSYBELLBIOPSYBELL SRLCIFOPACK WORKING CANNULA AND TROCAR TIP2023-06-15
08033860041687BIOPSYBELLBIOPSYBELL SRLCIFOPACK WORKING CANNULA AND DIAMOND TIP2023-06-15
08033860037482BIOPSYBELL SRLBIOPSYBELL SRLVERTEMAX KYPHOPLASTY TOOLS KIT2023-06-13
08033860037499BIOPSYBELL SRLBIOPSYBELL SRLVERTEMAX KYPHOPLASTY TOOLS KIT2023-06-13
08033860037505BIOPSYBELL SRLBIOPSYBELL SRLVERTEMAX WORKING CANNULA AND BEVEL TROCAR TIP2023-06-13
08033860037512BIOPSYBELL SRLBIOPSYBELL SRLVERTEMAX WORKING CANNULA AND BEVEL TROCAR TIP2023-06-13
08033860017927BIOPSYBELLBIOPSYBELL SRLBONE ACCESS NEEDLE2023-06-12
08033860024857BIOPSYBELLBIOPSYBELL SRLBONE ACCESS NEEDLE2023-06-12
00763000600167OSTEOCOOL BONE ACC 10G 090MEDTRONIC SOFAMOR DANEK, INC.OCN002HB2023-04-21
08033860036430BIOPSYBELLBIOPSYBELL SRLBONE ACCESS NEEDLE2022-09-30
08033860025076BIOPSYBELLBIOPSYBELL SRLBONE ACCESS NEEDLE2022-09-29
08033860015381BIOPSYBELLBIOPSYBELL SRLRENOVA SPINE WORKING CANNULA AND DIAMOND TIP2022-09-16
08033860037321BIOPSYBELL SRLBIOPSYBELL SRLRENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVEL2022-09-28
08033860038267BIOPSYBELL SRLBIOPSYBELL SRLRENOVA SPINE KYPHOPLASTY TOOL KIT2022-09-28
08033860038694BIOPSYBELL SRLBIOPSYBELL SRLRENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVEL2022-09-28
08033860039240BIOPSYBELL SRLBIOPSYBELL SRLRENOVA SPINE KYPHOPLASTY TOOL KIT2022-09-28
08033860020033BIOPSYBELLBIOPSYBELL SRLK-WIRE2022-09-19
08033860020040BIOPSYBELLBIOPSYBELL SRLK-WIRE2022-09-19
08033860020071BIOPSYBELLBIOPSYBELL SRLK-WIRE2022-09-19
08033860020088BIOPSYBELLBIOPSYBELL SRLK-WIRE2022-09-19
08033860025434BIOPSYBELLBIOPSYBELL SRLK-WIRE2022-09-19
08033860025441BIOPSYBELLBIOPSYBELL SRLK-WIRE2022-09-19
08033860025458BIOPSYBELLBIOPSYBELL SRLK-WIRE2022-09-19
08033860025465BIOPSYBELLBIOPSYBELL SRLK-WIRE2022-09-19
08033860037901BIOPSYBELLBIOPSYBELL SRLK-WIRE2022-09-19
00763000114510Kyphon Assist Directional Cannula Size 2MEDTRONIC SOFAMOR DANEK, INC.T34S2022-07-21
00643169097278KYPHON® Introducer Tool KitMEDTRONIC SOFAMOR DANEK, INC.T01A2021-10-02
00643169637474Kyphon V™ Osteo Introducer® 13Ga BevelMEDTRONIC SOFAMOR DANEK, INC.VPT13B2021-10-03