FDA.report

Inflatable bone tamp

Definition
A catheter-like device with an inflatable balloon at the distal end used for the reduction of fractures and/or creation of a void in cancellous bone [e.g., in the spine for a vertebral compression fracture (VCF), hand, tibia, radius, and calcaneus]. It is commonly used for kyphoplasty, which involves its insertion into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated. After the device is removed, orthopaedic bone cement is introduced into the created void to stabilize the vertebra. This is a single-use device.
GUDID devices
188
Last updated
2025-04-28 11:26:05

Related Product Codes

CodeDeviceSpecialtyClassDevices
HRXArthroscopeOrthopedic2120
NDNCement, Bone, VertebroplastyOrthopedic246
HXGTampOrthopedic121
OJVSingle Use Instrument TrayGeneral, Plastic Surgery18

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00884450815465Arcadia™Merit Medical Systems, Inc.F2025-04-18
00884450815441Arcadia™Merit Medical Systems, Inc.G2025-04-15
00884450815724Arcadia™Merit Medical Systems, Inc.F2025-04-11
00884450815496Arcadia™Merit Medical Systems, Inc.F2025-04-10
00884450790502Arcadia™Merit Medical Systems, Inc.D2025-03-24
00884450790564Arcadia™Merit Medical Systems, Inc.D2025-03-07
00884450815526Arcadia™Merit Medical Systems, Inc.F2025-03-07
00884450790410Arcadia™Merit Medical Systems, Inc.D2025-03-06
00884450790533Arcadia™Merit Medical Systems, Inc.D2025-03-06
00884450790557Arcadia™Merit Medical Systems, Inc.D2025-03-06
00884450790779Arcadia™Merit Medical Systems, Inc.D2025-03-06
00884450815786Arcadia™Merit Medical Systems, Inc.G2025-03-01
00884450815519Arcadia™Merit Medical Systems, Inc.G2025-01-24
00884450815359Arcadia™Merit Medical Systems, Inc.G2025-01-15
00884450815717Arcadia™Merit Medical Systems, Inc.G2025-01-15
00884450815748Arcadia™Merit Medical Systems, Inc.G2025-01-15
00884450815489Arcadia™Merit Medical Systems, Inc.G2024-11-26
00884450815540Arcadia™Merit Medical Systems, Inc.G2024-11-26
00884450780138Arcadia™Merit Medical Systems, Inc.F2024-11-02
10884450845308KyphoFlex™Merit Medical Systems, Inc.Initial Release2024-10-25
10884450845315KyphoFlex™Merit Medical Systems, Inc.Initial Release2024-10-25
10884450845322KyphoFlex™Merit Medical Systems, Inc.Initial Release2024-10-25
00884450780206Arcadia™Merit Medical Systems, Inc.F2024-10-09
00884450780404Arcadia™Merit Medical Systems, Inc.F2024-10-02
00884450780398Arcadia™Merit Medical Systems, Inc.F2024-04-23
08800038058279SYNTH™ PLUSIMEDICOM CO., LTD.PBES202024-03-25
08800038058286SYNTH™ PLUSIMEDICOM CO., LTD.PBES152024-03-25
08800038058293SYNTH™ PLUSIMEDICOM CO., LTD.PBES102024-03-25
08033860030179BIOPSYBELLBIOPSYBELL SRLKYPHOPLASTY BALLOON CATHETER2024-02-26
08800038056145SYNTH™ BESIMEDICOM CO., LTD.SYNTH BES102023-10-19
08800038056152SYNTH™ BESIMEDICOM CO., LTD.SYNTH BES152023-10-19
08800038056169SYNTH™ BESIMEDICOM CO., LTD.SYNTH BES202023-10-19
00884450748978Arcadia™Merit Medical Systems, Inc.008844507489782023-08-29
00884450490761Arcadia™Merit Medical Systems, Inc.008844504907612023-07-27
00884450490792Arcadia™Merit Medical Systems, Inc.008844504907922023-07-27
00884450490808Arcadia™Merit Medical Systems, Inc.008844504908082023-07-27
00884450497524Arcadia™Merit Medical Systems, Inc.008844504975242023-07-27
00884450749548Arcadia™Merit Medical Systems, Inc.008844507495482023-07-14
00884450749579Arcadia™Merit Medical Systems, Inc.008844507495792023-07-14
00884450748961Arcadia™Merit Medical Systems, Inc.008844507489612023-06-28
00884450749524Arcadia™Merit Medical Systems, Inc.008844507495242023-06-28
00884450749562Arcadia™Merit Medical Systems, Inc.008844507495622023-06-28
00884450749517Arcadia™Merit Medical Systems, Inc.008844507495172023-06-17
08033860030186BIOPSYBELLBIOPSYBELL SRLKYPHOPLASTY BALLOON CATHETER2023-06-12
08033860030193BIOPSYBELLBIOPSYBELL SRLKYPHOPLASTY BALLOON CATHETER2023-06-12
08033860037826BIOPSYBELLBIOPSYBELL SRLKYPHOPLASTY BALLOON CATHETER2023-06-12
00884450462478Arcadia™Merit Medical Systems, Inc.008844504624782023-03-02
08058964726339Winch Kyphoplasty ( 15 mm) 11 Gauge Balloon CatheterG21 SRL9000272017-05-17
08058964726407Winch Kyphoplasty ( 20 mm) 11 Gauge Balloon CatheterG21 SRL9000282017-05-17
00884450547540Arcadia™Merit Medical Systems, Inc.008844505475402022-12-03
00884450547526Arcadia™Merit Medical Systems, Inc.008844505475262022-06-17
00884450490907Arcadia™Merit Medical Systems, Inc.008844504909072022-06-08
00884450547359Arcadia™Merit Medical Systems, Inc.008844505473592022-05-20
H98103804500S0VBBSynthes GmbH03.804.500S2015-09-14
H98103804501S0VBBSynthes GmbH03.804.501S2015-09-14
H98103804502S0VBBSynthes GmbH03.804.502S2015-09-14
H98103804700S0SYNFLATESynthes GmbH03.804.700S2015-09-14
H98103804701S0SYNFLATESynthes GmbH03.804.701S2015-09-14
H98103804702S0SYNFLATESynthes GmbH03.804.702S2015-09-14
00884450547502Arcadia™Merit Medical Systems, Inc.008844505475022022-04-16
00884450447260Arcadia™Merit Medical Systems, Inc.008844504472602022-03-05
00884450547519Arcadia™Merit Medical Systems, Inc.008844505475192021-11-22
00884450547533Arcadia™Merit Medical Systems, Inc.008844505475332021-07-27
10884450490850Arcadia™Merit Medical Systems, Inc.008844504908532020-09-18
00884450547557Arcadia™Merit Medical Systems, Inc.008844505475572021-09-07
00884450490914Arcadia™Merit Medical Systems, Inc.008844504909142021-06-14
00884450490839Arcadia™Merit Medical Systems, Inc.008844504908392021-03-08
00763000311995KYPHON® Express™ Inflatable Bone TampMEDTRONIC SOFAMOR DANEK, INC.K15A2020-10-31
00884450490846Arcadia™Merit Medical Systems, Inc.008844504908462020-10-30
00763000312053KYPHON Express II Inflatable Bone TampMEDTRONIC SOFAMOR DANEK, INC.KE2022020-10-25
00763000025823KYPHON® ELEMENT™MEDTRONIC SOFAMOR DANEK, INC.KR1532020-10-15
00884450447208Arcadia™Merit Medical Systems, Inc.008844504472082020-10-14
06938695546166KMC Balloon Catheter, 8 Gauge, 10mmShanghai Kinetic Medical Co., Ltd.KMC-003-102020-10-01
06938695546173KMC Balloon Catheter, 8 Gauge, 15mmShanghai Kinetic Medical Co., Ltd.KMC-003-152020-10-01
06938695546180KMC Balloon Catheter, 8 Gauge, 20mmShanghai Kinetic Medical Co., Ltd.KMC-003-202020-10-01
06938695546197KMC Balloon Catheter, 10 Gauge, 10mmShanghai Kinetic Medical Co., Ltd.KMC-004-102020-10-01
06938695546203KMC Balloon Catheter, 10 Gauge, 15mmShanghai Kinetic Medical Co., Ltd.KMC-004-152020-10-01
06938695546210KMC Balloon Catheter, 10 Gauge, 20mmShanghai Kinetic Medical Co., Ltd.KMC-004-202020-10-01
06938695546227KMC Balloon Catheter Curved, 10 Gauge, 45°, 15mmShanghai Kinetic Medical Co., Ltd.KMC-005-152020-10-01
06938695546234KMC Balloon Catheter Curved, 10 Gauge, 45°, 20mmShanghai Kinetic Medical Co., Ltd.KMC-005-202020-10-01