FDA.reportPublic FDA data

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
207
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00763000311711BevelMEDTRONIC SOFAMOR DANEK, INC.T15K2020-11-06
00763000311728TrocarMEDTRONIC SOFAMOR DANEK, INC.T34B2020-11-06
00763000311735KYPHON® EXPRESS™ Advanced Osteo Introducer® DeviceMEDTRONIC SOFAMOR DANEK, INC.T34C2020-11-06
00763000311742DiamondMEDTRONIC SOFAMOR DANEK, INC.T34D2020-11-06
00763000311759BevelMEDTRONIC SOFAMOR DANEK, INC.T34E2020-11-06
00763000311773KYPHON® Advanced Osteo Introducer® DeviceMEDTRONIC SOFAMOR DANEK, INC.A20A2020-11-06
00763000311797OSTEOCOOL KIT BONE ACCESS 8G 090MEDTRONIC SOFAMOR DANEK, INC.OCN0032020-11-06
00763000311803OSTEOCOOL KIT BONE ACCESS 10G 095MEDTRONIC SOFAMOR DANEK, INC.OCN0042020-11-06
00763000311810OSTEOCOOL KIT BONE ACCESS 13G 100MEDTRONIC SOFAMOR DANEK, INC.OCN0052020-11-06
0076300031185813Ga Cannula; Matched Bevel Tip StyletMEDTRONIC SOFAMOR DANEK, INC.VPT13B2020-11-06
06923558507569Kyphoplasty Tool KitJiangsu Changmei Medtech Co., Ltd.KT-00-052025-10-23
06923558509693Kyphoplasty Tool KitJiangsu Changmei Medtech Co., Ltd.KT-00-062025-10-23
08033860015374BIOPSYBELLBIOPSYBELL SRLRENOVA SPINE WORKING CANNULA AND DIAMOND TIP2022-09-16
08033860024772BIOPSYBELLBIOPSYBELL SRLBONE ACCESS NEEDLE2022-09-29
08033860025557BIOPSYBELLBIOPSYBELL SRLRENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCA2024-02-23
08033860028596BIOPSYBELLBIOPSYBELL SRLK-WIRE2022-09-16
08033860028602BIOPSYBELLBIOPSYBELL SRLK-WIRE2022-09-16
08033860030353BIOPSYBELLBIOPSYBELL SRLK-WIRE2022-09-16
08033860036300BIOPSYBELLBIOPSYBELL SRLBONE ACCESS NEEDLE2022-09-30
08033860038687BIOPSYBELL SRLBIOPSYBELL SRLRENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVEL2022-09-28
08033860044732BIOPSYBELLBIOPSYBELL SRLBONE ACCESS NEEDLE2024-04-12
08033860044756BIOPSYBELLBIOPSYBELL SRLBONE ACCESS NEEDLE2024-04-12
08033860046613BIOPSYBELLBIOPSYBELL SRLRENOVA SPINE KYPHOPLASTY TOOL KIT2025-10-27
10885380174186Aero-MedAERO-MED, LLCCA246752019-07-24
30850004171012Access & Cavity Creation KitLenoss Medical, Inc.4.6mm (7G)2023-01-12
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
M970210240040"0.035"" x 5"" K-Wire Standard"Trilliant 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