ClearanceBrief
Panels › Orthopedic › Product code NDN · Class 2

Cement, Bone, Vertebroplasty

Regulation 888.3027

1510(k)s in 12 months (108 all time)
0recalls in 12 months (86 all time)
51recalls that name a 510(k)
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Top companies in NDN

Company510(k)sRecalls
Zavation, LLC171
Depuy Spine, Inc.28
Stryker Corp.70
Teknimed Sas61
Arthrocare Corp.60
Medtronic50
Tecres S.P.A.50
Dfine, Inc.40
Disc-O-Tech Medical Technologies, Ltd.40
Medtronic Sofamor Danek30
Decided510(k)Device and applicantCode
Jan 28, 2026K251896XeliteMed SuperM-Fix Spinal Bone Cement
Xelite Biomed , Ltd., TW
NDN
May 30, 2025K250637VCFix Spinal System
Amber Implants, NL
NDN
Apr 11, 2025K243537XeliteMed VertehighFix High Viscosity Spinal Bone Cement System
Xelite Biomed , Ltd., TW
NDN
Sep 18, 2024K241775XeliteMed VertehighFix High Viscosity Spinal Bone Cement
Xelite Biomed , Ltd., TW
NDN
Feb 29, 2024K232842Balloon Inflation System
Ningbo Hicren Biotechnology Co., Ltd., CN
NDN
Feb 9, 2024K240084V-STRUT® Vertebral Implant
Hyprevention, FR
NDN
Oct 30, 2023K231340Renova Spine Balloon Catheter
Biopsybell S.R.L., IT
NDN
Mar 3, 2023K221697INJECTION PIN (KIP(02031-02061) (03031-03061))
Slk Ortho, LLC
NDN
Dec 20, 2022K223294SpineJack® Expansion Kit
Stryker Instruments
NDN
Apr 18, 2022K220131KYPHON VuE Bone Cement
Tecres S.P.A., IT
NDN
Oct 28, 2021K211797TRACKER Plus Kyphoplasty System
GS Medical Co., Ltd., KR
NDN
Jun 25, 2021K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement
Stryker Instruments
NDN
Oct 20, 2020K202393SpineJack Expansion Kit
Stryker Corporation
NDN
Aug 31, 2020K201831CONFIDENCE Spinal Cement System
Depuy Spine, Inc.
NDN
May 27, 2020K192449Joline Kyphoplasty System Allevo
Joline GmbH & Co. KG, DE
NDN
Mar 5, 2020K191709V-STRUT Vertebral Implant
Hyprevention Sas, FR
NDN
Dec 4, 2019K192335TRACKER Kyphoplasty System
GS Medical Co., Ltd., KR
NDN
Nov 8, 2019K192403VK100 Percutaneous Vertebral Augmentation System
Bonwrx, Ltd.
NDN
Aug 30, 2018K181262SpineJack Expansion Kit
Vexim SA, FR
NDN
May 29, 2018K172871SpineKure Kyphoplasty System
Hanchang Co., Ltd., KR
NDN
May 18, 2018K180700KYPHON HV-R Bone Cement
Medtronic Sofamor Danek USA, Inc.
NDN
Aug 23, 2017K172214Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters
G-21 S.R.L., IT
NDN
Apr 12, 2017K161114HIGH V+
Teknimed Sas, FR
NDN
Feb 27, 2017K163032Kyphon Xpede Bone Cement
Medtronic, Inc.
NDN
Feb 6, 2017K162283DCM Kyphoplasty System
Dragon Crown Medical Co., Ltd., CN
NDN
Jan 23, 2017K162618CONCORD Plus Radiopaque Bone Cement
Globus Medical, Inc.
NDN
Nov 1, 2016K16245313G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)
Pan Medical , Ltd., GB
NDN
Aug 24, 2016K160983Kyphon HV-R Bone Cement
Medtronic, Inc.
NDN
Jul 29, 2016K153296MEDINAUT Kyphoplasty System
Imedicom Co., Ltd., KR
NDN
Feb 23, 2016K152557Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters
G21, S.R.L., IT
NDN
Nov 16, 2015K151227KYPHON XPEDE Bone Cement
Medtronic
NDN
Jun 12, 2015K150582Vertaplex® High Viscosity (HV) Radiopaque Bone Cement
Stryker Corporation
NDN
Apr 28, 2015K150460KYPHON (R) HV-R(R) Bone Cement
Medtronic Sofamor Danck USA, Inc.
NDN
Apr 9, 2015K150607Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml
Osseon, LLC
NDN
Mar 6, 2015K150322InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15
Pan Medical , Ltd., GB
NDN
Jan 16, 2015K143006GUARDIAN-SG Inflatable Bone Expander System
Bm Korea Co., Ltd., KR
NDN
Sep 12, 2014K141419ZVPLASTY
Zavation, LLC
NDN
Aug 21, 2014K141930OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML
Osseon, LLC
NDN
Aug 14, 2014K141141KIVA VCF TREATMENT SYSTEM
Benvenue Medical, Inc.
NDN
Jun 19, 2014K140937OSSEOFLEX SB
Osseon, LLC
NDN
Apr 16, 2014K132620INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL
Pan Medical , Ltd., GB
NDN
Apr 4, 2014K133669MEDINAUT KYPHOPLASTY SYSTEM
Imedicom
NDN
Jan 24, 2014K132817KIVA VCF TREATMENT SYSTEM
Benvenue Medical, Inc.
NDN
Dec 6, 2013K133372CROSSTREES PVA POD
Crosstrees Medical, Inc.
NDN
Aug 9, 2013K130089CROSSTREES PVA POD
Crosstrees Medical, Inc.
NDN
Jun 25, 2013K122503PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON
Neuro Therm, Inc.
NDN
May 20, 2013K130146SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM
Synthes (Usa), LLC
NDN
Apr 3, 2013K123942STRYKER IVAS BALLOON CATHETER
Stryker Corporation
NDN
Apr 1, 2013K130402SPIDER SYSTEM KOLIBRI CEMENT NEEDLE
Sintea Plustek, LLC
NDN
Mar 28, 2013K122175MENDEC SPINE HV, MENDEC SPINE HV SYSTEM
Tecres S.P.A.
NDN

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