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NKB

905 FDA 510(k) clearances · Product code

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RecordFirmDate
Invictus™ Spinal Fixation System (K203056)Alphatec Spine, Inc.2020-11-23
Calvary Spine Pedicle Screw System (K201568)Calvary Spine, LLC2020-11-12
Salvo® Spine System (K202476)Spine Wave, Inc.2020-11-05
LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System (K200790)L&K BIOMED Co., Ltd.2020-10-28
ACURA Stabilization System (K200937)Indius Medical Technologies Pvt. , Ltd.2020-10-26
Cannulated Power Driver Attachment (K202528)K2m, Inc.2020-10-26
Wiltrom Spinal Fixation System (K202894)Wiltrom Corporation Limited2020-10-23
Trivergent Spinal Fixation System (K201427)Benvenue Medical, Inc.2020-10-21
AccelFix Spinal Fixation System (K200794)L&K BIOMED Co., Ltd.2020-10-20
CD Horizon Spinal System (K202771)Medtronic2020-10-19
Invictus™ OsseoScrew® System (K202327)Alphatec Spine, Inc.2020-10-15
KHEIRON® Spinal Fixation System (K201659)S.M.A.I.O2020-10-05
CD Horizon™ Spinal System (K201407)Medtronic Sofamor Danek USA, Inc.2020-09-10
CD Horizon Spinal System (K202328)Medtronic Sofamor Danek USA, Inc.2020-09-08
ORION Spinal System (K190600)Orion Biotech, Inc.2020-08-18
Mega Plus MIS Spine System (K200981)Bk Meditech, Co., Ltd.2020-08-11
CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System (K201926)CarboFix Orthopedics , Ltd.2020-08-07
Sterispine™ PS (K201648)Safe Orthopaedics2020-07-30
True Tulip System, True M.I.S. System (K201780)Innovative Surgical Designs, Inc.2020-07-22
Pedicle Screw System (K201751)Black Box Medical, LLC2020-07-22
Spinal Fixation System (K190408)Shangdong Kangsheng Medical Devices Co., Ltd.2020-06-16
Altus Spine Pedicle Screw System (K200322)Altus Partners, LLC2020-06-02
VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 (K193423)Icotec AG2020-05-22
Reform Pedicle Screw System (K200303)Precision Spine2020-05-19
Dymaxeon Spine System (K192930)Back 2 Basics Direct, LLC2020-05-12
CarboClear® II Pedicle Screw System (K200519)CarboFix Orthopedics , Ltd.2020-04-30
EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System (K200245)Medos International Sàrl2020-04-24
Stryker Xia 3 Power Adaptor (K200666)Stryker Spine2020-04-23
ARx Spinal System (K200070)Life Spine, Inc.2020-04-23
RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System (K193100)OrthoPediatrics Corp.2020-03-24
Nano FortiFix® System (K193211)Nanovis Spine, LLC2020-03-20
MEGAFIX® Pedicle Screw Spinal System (K191655)Seohancare Co., Ltd.2020-03-06
LOSPA® IS™ Spinal Fixation System (K200267)Corentec Co., Ltd.2020-03-06
Daytona® Small Stature Spinal System (K200381)SeaSpine Orthopedics Corporation2020-02-28
OrthoCircle Spine Pedicle Screw System (K193472)Orthocircle Spine2020-02-13
PERLA® TL posterior osteosynthesis system (K193396)Spineart2020-02-05
CapLOX II®/TowerLOX® MIS Pedicle Screw System (K193270)Captiva Spine, Inc.2020-01-31
M.U.S.T. Pedicle Screw System (K193365)Medacta International S.A.2020-01-27
NEX-D2 Posterior Fixation System (K190981)Next Orthosurgical2020-01-15
Streamline TL Spinal Fixation System (K192800)Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2020-01-14
CD Horizon™ Fenestrated Screw Set (K193011)Medtronic Sofamor Danek USA, Inc.2020-01-10
CorticaLINK Spinal Fusion Platform (K193465)Spine Smith Holdings, LLC2020-01-10
Percusys® Plus Pedicle Screw System (K192680)Joimax GmbH2019-12-18
G Surgical Marksman System (K193219)G Surgical, LLC2019-12-17
Invictus™ Spinal Fixation System (K192938)Alphatec Spine, Inc.2019-12-12
Streamline MIS Spinal Fixation System (K192396)Pioneer Surgical Technology, Inc.2019-11-26
GMA 2.0 Pedicle Screw System (K192915)Grafton Medical Alliance2019-11-13
Black Diamond Pedicle Screw System (K192121)Osseus Fusion Systems2019-10-29
Europa Pedicle Screw System (K192268)MiRus, LLC2019-10-22
NuVasive® Reline® 4.5-5.0 System (K190636)Nu Vasive, Incorporated2019-10-19
Momentum™ Posterior Spinal Fixation System (K191932)Ulrich Medical USA2019-10-02
Mercury® Spinal System, Overwatch® Spinal System (K191576)Spinal Elements, Inc.2019-09-16
mont blanc & mont blanc MIS Spinal Systems (K191726)Spineway SA2019-09-12
Curiteva Pedicle Screw System (K191810)Curiteva, Inc.2019-08-28
Facilis™ Spinal System (K191494)Baui Biotech Co., Ltd.2019-08-12
ARx Spinal System (K191575)Life Spine, Inc.2019-08-08
CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments (K191835)Globus Medical, Inc.2019-08-06
Elaris Pedicle Screw System (K183091)Spinewelding AG2019-08-02
4CIS® Chiron Spinal Fixation System (K190471)Solco Biomedical Co., Ltd.2019-07-24
Mariner MIS Pedicle Screw System; SeaSpine Navigation System (K191648)SeaSpine Orthopedics Corporation2019-07-19
EUROPA Pedicle Screw System (K191757)MiRus, LLC2019-07-19
Salvo™ Spine System (K191045)Spine Wave, Inc.2019-07-10
LineSider™ Spinal System (K190360)Integrity Implants, Inc.2019-06-21
VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 (K190545)Icotec AG2019-06-20
The JASPER Spinal Fixation System II (K190762)Gbs Commonwealth Co., Ltd.2019-06-19
NOVA Minimally Invasive System (K182416)Baui Biotech Co., Ltd.2019-06-11
AccelFix Spinal Fixation System (K182544)L&K BIOMED Co., Ltd.2019-05-28
Mariner Outrigger Revision System (K183639)SeaSpine Orthopedics Corporation2019-05-23
KeYi Spinal Fixation System (K190567)Beijing Keyi Medical Device Technology Co., Ltd.2019-05-08
PASS LP Spinal System (K190376)Medicrea International SA2019-05-02
Zavation Spinal System (K190317)Zavation Medical Products, LLC2019-04-11
CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS® (K182375)Globus Medical, Inc.2019-04-08
Vitality® Spinal Fixation System (K183550)Zimmer Biomet Spine, Inc.2019-04-08
Zavation Spinal System (K190361)Zavation Medical Products, LLC2019-03-18
EUROPA Pedicle Screw System (K180337)MiRus, LLC2019-03-14
Modular Spinal Fixation System (K183430)Life Spine, Inc.2019-03-13
ISS-JAZZ Screw System and JAZZ CAP SP (K182771)Implanet, S.A.2019-03-12
NuVasive Reline System (K182974)Nu Vasive, Incorporated2019-02-13
Pedimax II - Pedicular Screw Spinal System (K180626)Gm Dos Reis Industria E Comerico Ltda.2019-02-01
EUROPA™ Pedicle Screw System (K182970)MiRus, LLC2019-01-22
Whistler Modular Pedicle Screw System (K182478)Evolution Spine, LLC2019-01-15
CBT Screw Fixation System (K181824)U&I Corporation2018-12-13
Salvo™ Spine System (K182954)Spine Wave, Inc.2018-12-12
LEUCADIA AUTOLOK™ Pedicle Screw System (K182339)Clearview Orthopedic Development, LLC2018-12-12
OpenLoc-L Spinal Fixation System (K183168)L&K BIOMED Co., Ltd.2018-12-11
Mega Plus Spine System (K183080)Bk Meditech, Co., Ltd.2018-12-10
C-Zero Pedicle Screw System, Freedom Pedicle Screw System (K180754)Signature Orthopaedics Pty, Ltd.2018-12-07
PathLoc-L MIS Spinal System (K183117)L&K BIOMED Co., Ltd.2018-11-15
VersaLink™ Fixation System (K182598)Premia Spine, Ltd.2018-11-13
ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System (K180980)Camber Spine Technologies, LLC2018-10-27
FUSE Pedicle Screw System (K182283)Black Box Medical2018-10-23
OLYMPIC Posterior Spinal Fixation System (K182239)Astura Medical, LLC2018-10-18
PASS LP Spinal System (K182240)Medicrea International SA2018-10-17
Cellent Spinal Systems (K172826)Jiangsu Trauhui Medical Instrument Co., Ltd.2018-10-10
Prase MIS Spinal System (K182059)Gbs Commonwealth Co., Ltd.2018-10-04
CarboClear® Pedicle Screw System (K182377)CarboFix Orthopedics , Ltd.2018-09-27
OsseoScrew System (K181980)Alphatec Spine, Inc.2018-09-25
Chiral Surgical Pedicle Screw System (K181995)Chiral Surgical2018-09-20
Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System (K181390)OrthoPediatrics Corp.2018-09-18
MOSS VRS Spinal System (K181821)Biedermann Motech GmbH & Co. KG2018-09-13
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