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Cement, Bone, Vertebroplasty

FDA product code NDN · 95 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3027
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 2004-04-01 – 2026-01-28

NDN 2026-01-28

XeliteMed SuperM-Fix Spinal Bone Cement

Applicant Xelite Biomed , Ltd.

K number K251896

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NDN 2025-05-30

VCFix Spinal System

Applicant Amber Implants

K number K250637

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NDN 2025-04-11

XeliteMed VertehighFix High Viscosity Spinal Bone Cement System

Applicant Xelite Biomed , Ltd.

K number K243537

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NDN 2024-09-18

XeliteMed VertehighFix High Viscosity Spinal Bone Cement

Applicant Xelite Biomed , Ltd.

K number K241775

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NDN 2024-02-29

Balloon Inflation System

Applicant Ningbo Hicren Biotechnology Co., Ltd.

K number K232842

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NDN 2024-02-09

V-STRUT® Vertebral Implant

Applicant Hyprevention

K number K240084

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NDN 2023-10-30

Renova Spine Balloon Catheter

Applicant Biopsybell S.R.L.

K number K231340

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NDN 2023-03-03

INJECTION PIN (KIP(02031-02061) (03031-03061))

Applicant Slk Ortho, LLC

K number K221697

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NDN 2022-12-20

SpineJack® Expansion Kit

Applicant Stryker Instruments

K number K223294

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NDN 2022-04-18

KYPHON VuE Bone Cement

Applicant Tecres S.P.A.

K number K220131

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NDN 2021-10-28

TRACKER Plus Kyphoplasty System

Applicant GS Medical Co., Ltd.

K number K211797

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NDN 2021-06-25

SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement

Applicant Stryker Instruments

K number K211238

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NDN 2020-10-20

SpineJack Expansion Kit

Applicant Stryker Corporation

K number K202393

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NDN 2020-08-31

CONFIDENCE Spinal Cement System

Applicant Depuy Spine, Inc.

K number K201831

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NDN 2020-05-27

Joline Kyphoplasty System Allevo

Applicant Joline GmbH & Co. KG

K number K192449

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NDN 2020-03-05

V-STRUT Vertebral Implant

Applicant Hyprevention Sas

K number K191709

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NDN 2019-12-04

TRACKER Kyphoplasty System

Applicant GS Medical Co., Ltd.

K number K192335

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NDN 2019-11-08

VK100 Percutaneous Vertebral Augmentation System

Applicant Bonwrx, Ltd.

K number K192403

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NDN 2018-08-30

SpineJack Expansion Kit

Applicant Vexim SA

K number K181262

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NDN 2018-05-29

SpineKure Kyphoplasty System

Applicant Hanchang Co., Ltd.

K number K172871

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NDN 2018-05-18

KYPHON HV-R Bone Cement

Applicant Medtronic Sofamor Danek USA, Inc.

K number K180700

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NDN 2017-08-23

Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters

Applicant G-21 S.R.L.

K number K172214

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NDN 2017-04-12

HIGH V+

Applicant Teknimed Sas

K number K161114

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NDN 2017-02-27

Kyphon Xpede Bone Cement

Applicant Medtronic, Inc.

K number K163032

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NDN 2017-02-06

DCM Kyphoplasty System

Applicant Dragon Crown Medical Co., Ltd.

K number K162283

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NDN 2017-01-23

CONCORD Plus Radiopaque Bone Cement

Applicant Globus Medical, Inc.

K number K162618

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NDN 2016-11-01

13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)

Applicant Pan Medical , Ltd.

K number K162453

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NDN 2016-08-24

Kyphon HV-R Bone Cement

Applicant Medtronic, Inc.

K number K160983

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NDN 2016-07-29

MEDINAUT Kyphoplasty System

Applicant Imedicom Co., Ltd.

K number K153296

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NDN 2016-02-23

Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters

Applicant G21, S.R.L.

K number K152557

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NDN 2013-12-06

CROSSTREES PVA POD

Applicant Crosstrees Medical, Inc.

K number K133372

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NDN 2013-08-09

CROSSTREES PVA POD

Applicant Crosstrees Medical, Inc.

K number K130089

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NDN 2013-06-25

PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON

Applicant Neuro Therm, Inc.

K number K122503

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NDN 2013-05-20

SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM

Applicant Synthes (Usa), LLC

K number K130146

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NDN 2013-04-03

STRYKER IVAS BALLOON CATHETER

Applicant Stryker Corporation

K number K123942

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NDN 2013-04-01

SPIDER SYSTEM KOLIBRI CEMENT NEEDLE

Applicant Sintea Plustek, LLC

K number K130402

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NDN 2013-03-28

MENDEC SPINE HV, MENDEC SPINE HV SYSTEM

Applicant Tecres S.P.A.

K number K122175

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NDN 2012-12-14

ASCENDX VCF REDUCTION SYSTEM

Applicant Aoi Medical, Inc.

K number K100404

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NDN 2012-10-23

OSSEOFLEX SB INFLATABLE BONE TAMP

Applicant Osseon Therapeutics, Inc.

K number K122533

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NDN 2012-10-19

VERTECEM II CEMENT KIT

Applicant Aap Biomaterials GmbH

K number K121876

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NDN 2012-09-17

KMC KYPHOPLASTY SYSTEM

Applicant Shanghai Kinetic Medical Co., Ltd.

K number K113742

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NDN 2012-02-17

ACU-CUT VERTEBRAL AUGMENTATION SYSTEM

Applicant Ascendx Spine, Inc.

K number K113452

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NDN 2012-01-24

IVAS BALLOON CATHETER

Applicant Stryker Corporation

K number K113154

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NDN 2012-01-06

IVAS 20MM (10 GAUGE) BALLOON CATHETER

Applicant Stryker Instruments, Instruments Div.

K number K113477

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NDN 2011-12-22

CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G

Applicant Medos International SARL

K number K112907

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NDN 2011-12-13

VBB SYSTEM

Applicant Synthes

K number K110604

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NDN 2011-12-08

SHIELD KYPHOPLASTY SYSTEM

Applicant Soteira, Inc.

K number K093477

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NDN 2011-11-18

GUARDIAN INFLATABLE BONE EXPANDER SYSTEM

Applicant Bm Korea Co., Ltd.

K number K111593

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NDN 2011-10-25

AFFIRM (TM) VCF SYSTEM

Applicant Algea Therapies

K number K110998

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NDN 2011-06-28

IVAS 2-10MM (10 GUAGE) BALLON CATHETER

Applicant Stryker Corporation

K number K103807

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NDN 2011-02-28

KYPHON XPEDE BONE CEMENT

Applicant Medtronic

K number K102397

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NDN 2011-02-16

ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE

Applicant Arthrocare Corp.

K number K110183

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NDN 2011-02-04

COHESION BONE CEMENT

Applicant Teknimed Sas

K number K103816

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NDN 2011-01-10

AVAMAX VERTEBRAL BALLOON

Applicant Care Fusion

K number K103064

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NDN 2011-01-03

F20

Applicant Teknimed, S.A.

K number K103433

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NDN 2010-09-21

PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE

Applicant Arthrocare Corp.

K number K100479

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NDN 2010-08-12

KYPH X HV-R BONE CEMENT

Applicant Medtronic, Inc.

K number K093828

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NDN 2010-03-18

IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVAS

Applicant Stryker Instruments, Instruments Div.

K number K093419

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NDN 2010-02-26

AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020

Applicant Care Fusion

K number K093463

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NDN 2010-02-16

SKELTEX ISV

Applicant Skeltex Technologies, Inc.

K number K091234

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NDN 2009-12-30

STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT)

Applicant Dfine, Inc.

K number K090986

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NDN 2009-12-21

VERTECEM

Applicant Teknimed, S.A.

K number K090435

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NDN 2009-10-23

VERTAPLEX HV (SINGLE PACK AND DUAL PACK)

Applicant Stryker Corp.

K number K091606

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NDN 2009-07-01

INFLATABLE BONE TAMP

Applicant Cardinal Health, Inc.

K number K090211

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NDN 2009-06-05

CORTOSS BONE AUGMENTATION MATERIAL

Applicant Orthovita, Inc.

K number K080108

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NDN 2009-04-14

BONOS INJECT

Applicant Aap Biomaterials GmbH

K number K090460

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NDN 2008-08-28

OPACITY + BONE CEMENT

Applicant Teknimed, S.A.

K number K080873

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NDN 2007-12-21

MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE)

Applicant Disc-O-Tech Medical Technologies, Ltd.

K number K071375

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NDN 2007-12-07

STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT

Applicant Stryker Corp.

K number K072118

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NDN 2007-11-21

MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT

Applicant Depuy Spine, A Johnson & Johnson Company

K number K071927

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NDN 2007-11-20

AVAFLEX VERTEBRAL AUGMENTATION NEEDLE

Applicant Cardinal Health, Inc.

K number K072133

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NDN 2007-10-05

MODIFICATION TO SPACE CPSXL BONE CEMENT

Applicant Dfine, Inc.

K number K072496

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NDN 2007-06-29

SPACE 360 DELIVERY SYSTEM

Applicant Dfine, Inc.

K number K070351

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NDN 2007-05-04

ARCUATE VERTEBRAL AUGMENTATION SYSTEM

Applicant Medtronic Sofamor Danek

K number K070527

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NDN 2007-03-13

ARCUATE VERTEBRAL AUGMENTATION SYSTEM

Applicant Medtronic Sofamor Danek

K number K063248

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NDN 2007-01-17

VSPSPN

Applicant Tecres S.P.A.

K number K063438

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NDN 2006-11-03

CONFIDENCE FENESTRATED INTRODUCER NEEDLE

Applicant Disc-O-Tech Medical Technologies, Ltd.

K number K063067

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NDN 2006-09-21

KIT MENDEC SPINE AND DELIVERY SYSTEM

Applicant Tecres S.P.A.

K number K062452

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NDN 2006-09-14

CONFIDENCE EX HIGH VISCOSITY BONE CEMENT

Applicant Disc-O-Tech Medical Technologies, Ltd.

K number K062424

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NDN 2006-08-30

SPACE CPSXL BONE CEMENT

Applicant Dfine, Inc.

K number K061531

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NDN 2006-07-12

PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS-TA

Applicant Arthrocare Corp.

K number K060425

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NDN 2006-07-03

STAXX FX SYSTEM

Applicant Spine Wave, Inc.

K number K053336

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NDN 2006-06-21

CONFIDENCE HIGH VISCOSITY BONE CEMENT

Applicant Disc-O-Tech Medical Technologies, Ltd.

K number K060300

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NDN 2006-03-17

SPINE-FIX BIOMIMETIC BONE CEMENT

Applicant Teknimed, S.A.

K number K043593

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NDN 2006-03-13

EBI VERTEBROPLASTY SYSTEMS

Applicant Ebi, L.P.

K number K060148

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NDN 2006-01-25

PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS

Applicant Arthrocare Corp.

K number K053180

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NDN 2005-11-08

VERTEFIX VERTEBROPLASTY PROCEDURE SET

Applicant Cook, Inc.

K number K042691

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NDN 2005-07-15

VERTEBROPLASTIC RADIOPAQUE BONE CEMENT

Applicant Depuy Spine, Inc.

K number K043406

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NDN 2005-06-17

PARALLAX ACRYLIC RESIN WITH TRACERS TA

Applicant Arthrocare Corp.

K number K050864

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NDN 2005-06-09

MENDEC SPINE

Applicant Tecres S.P.A.

K number K042415

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NDN 2005-05-11

RADIOPAQUE BONE CEMENT

Applicant Cardinalhealth

K number K043518

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NDN 2005-01-14

CONCORD Radiopaque Bone Cement

Applicant Globus Medical, Inc.

K number K042168

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NDN 2004-12-27

PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003

Applicant Arthrocare Corp.

K number K042947

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NDN 2004-07-07

KYPHX HV-R BONE CEMENT, MODEL C01A

Applicant Kyphon, Inc.

K number K041584

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NDN 2004-04-01

KYPHX HV-R, MODEL C01A

Applicant Kyphon, Inc.

K number K033801

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