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NKB

905 FDA 510(k) clearances · Product code

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RecordFirmDate
CD HORIZON™ Spinal System (K182119)Medtronic Sofamor Danek USA, Inc.2018-08-29
Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX™ Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated Screw (K180179)Orthofix, Inc.2018-08-24
Zenius™, Iliad™ and Kora™ Spinal Fixation Systems (K181978)Medyssey USA, Inc.2018-08-13
Redi-Spine (K181584)Innovative Surgical Designs, Inc.2018-08-10
Kodiak Spinal Fixation System (K181677)Alphatec Spine, Inc.2018-08-09
Stowe Pedicle Screw System (K181554)Black Box Medical2018-07-27
Republic Spine Dark Star Spinal System (K181495)Republic Spine, LLC2018-07-25
TREND II Spinal Fixation System- STEP Series (K180226)Paonan Biotech Co., Ltd.2018-07-25
Altus Spine Pedicle Screw System (K181339)Altus Partners, LLC2018-07-24
JASPER Spinal Fixation System (K173645)Gbs Commonwealth Co., Ltd.2018-07-23
CarboClear® Pedicle Screw System (K173487)CarboFix Orthopedics , Ltd.2018-07-18
Viking Lumbar Polyaxial Screw System (K180655)Presidio Surgical2018-07-13
OLYMPIC Posterior Spinal Fixation System (K181139)Astura Medical, LLC2018-07-06
Range (Denali and Mesa) Spinal Systems (K181119)K2m, Inc.2018-06-26
Altus Spine Pedicle Screw System (K181281)Altus Partners, LLC2018-06-11
EVEREST Spinal System (K181188)K2m, Inc.2018-05-30
SAGICO OSI Spinal System by Osimplant (K180220)Spinal Analytics & Geometrical Implant Co, LLC2018-05-21
SeaSpine Daytona Small Stature Spinal System (K180686)SeaSpine Orthopedics Corporation2018-05-14
ENNOVATE® (K180433)Aesculap Implant Systems, LLC2018-04-26
FOCUS Pedicle Screw System (K180458)Nvision Biomedical Technologies, LLC2018-04-17
AXIS 5.5 Lumbar Pedicle Screw System (K180301)Axis Orthopaedics2018-04-10
Mercury® Spinal System (K172967)Spinal Elements, Inc.2018-04-10
Patriot Spinal Fixation System (K180324)Valorus Spine2018-04-06
K2M Patient Specific Rods (K180376)K2m, Inc.2018-04-05
CREO® Stabilization System (K180210)Globus Medical, Inc.2018-04-02
CapLOX II® / TowerLOX® MIS Pedicle Screw System (K180475)Captiva Spine, Inc.2018-03-19
X-spine Cortical Bone Screw System (K180153)X-Spine Systems, Inc.2018-03-15
Mega Plus Spine System (K173180)Bk Meditech, Co., Ltd.2018-03-15
CD HORIZON™ Spinal System (K173249)Medtronic Sofamor Danek USA, Inc.2018-03-08
IRENE Thoracolumbar Fixation System (K172267)Tianjin Zhengtian Medical Instrument Co., Ltd.2018-03-06
SeaSpine NewPort Spinal System (K180176)SeaSpine Orthopedics Corporation2018-02-20
SEURAT™ Universal Pedicle Screw System (K173185)Ctl Medical Corporation2018-02-14
SeaSpine Mariner Pedicle Screw System (K173882)SeaSpine Orthopedics Corporation2018-02-06
DeGen Medical E3 MIS Pedicle Screw System (K173814)Degen Medical2018-01-29
Wiltrom Spinal Fixation System (K172548)Wiltrom Corporation Limited2018-01-12
VERTICALE® Posterior Spinal Fixation System/VERTICALE® System (K171421)Silony Medical GmbH2018-01-10
Everest Spinal System (K173508)K2m2018-01-09
Reform® Midline Cortical Screw System (K173130)Precision Spine, Inc.2017-12-19
ANAX 5.5™ Spinal System (K173524)U&I Corporation2017-12-13
CorticaLINK Spinal Fusion Platform (K173484)Linkspine, Inc.2017-12-11
Rexious Spinal Fixation System (K173131)Huvexel Co. , Ltd.2017-12-08
Arisstos™ Spinal System (K173126)Ingenium Spine2017-12-05
TiLock Modular Spinal System (K172469)Genesys Spine2017-11-30
Solanas® Posterior Stabilization System (K173522)Alphatec Spine, Inc.2017-11-30
VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with Fenestrations (K173095)Medos International SARL2017-10-25
CosmoLock Pedicle Screw System (K172808)Kalitec Direct, LLC2017-10-25
AnyPlus® Spinal Fixation System (K172546)GS Medical Co., Ltd.2017-10-23
XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory (K172724)Stryker Corporation2017-10-10
NuVasive® Precept™ Spinal System (K171894)Nu Vasive, Incorporated2017-09-28
Vitality® Spinal Fixation System, Vitality®+ Power Instrument System (K172275)Zimmer Biomet Spine, Inc.2017-09-27
ROMEO® 2 Posterior Osteosynthesis System (K172101)Spineart2017-09-26
Range/Denali/Mesa Spinal System (K171832)K2m, Inc.2017-09-14
NEO Pedicle Screw System™ (K171582)Neo Medical SA2017-09-12
Additional VIPER PRIME™ screws with fenestrations (K171570)Medos International SARL2017-08-31
Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™ Pedicular Fixation System, Palisade™ Pedicular Fixation System (K172107)Spineology, Inc.2017-08-21
Zenius™, lliad™ and Kora™ Spinal Fixation Systems (K171526)Medyssey USA, Inc.2017-08-21
CapSure® PS System (K172175)Spine Wave, Inc.2017-08-16
Paonan Armstrong Posterior Spinal Fixation System (K161225)Paonan Biotech Co., Ltd.2017-08-11
Premier (K170861)Shandong Weigao Orthopaedic Device Co., Ltd.2017-08-04
Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems (K171456)Choicespine2017-08-03
M.U.S.T. Combined Set Screws (K171758)Medacta International S.A.2017-08-01
True Spinal Fixation System (K171559)Innovative Surgical Designs, Inc.2017-07-24
TiLock2 Spinal System (K171838)Genesys Spine2017-07-19
True Spinal Fixation System (K170710)Innovative Surgical Designs, Inc.2017-07-14
Vitality® Spinal Fixation System (K171907)Zimmer Biomet Spine, Inc.2017-07-14
OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System (K171813)L&K BIOMED Co., Ltd.2017-07-13
PHA S1 Spinal System (K163011)Phamedica, Inc.2017-06-29
Swedge™ Pedicle Screw Fixation System (K170045)Spinal Resources, Inc.2017-06-26
Iliad® Pedicle Screw System and Zenius® Pedicle Screw System (K171509)Medyssey USA, Inc.2017-06-12
ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System (K170821)Choicespine, LP2017-06-08
Palisade™ Pedicular Fixation System (K171438)Spineology, Inc.2017-06-02
M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws (K171170)Medacta International S.A.2017-05-25
SETx Pedicle Screw System (K170611)Xenco Medical, LLC2017-05-25
Dymaxeon Spine System (K170989)Back 2 Basics Direct, LLC2017-05-22
Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory (K170496)Stryker Corporation2017-05-16
CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems (K170679)Medtronic Sofamor Danek2017-05-11
Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System (K171082)Orthofix, Inc.2017-05-05
VIPER PRIME™ Screws with Fenestrations (K170543)Medos International SARL2017-05-04
Xultan 5.5 Pedicle Screw System (K170108)Met One Technologies2017-05-02
Zenius Spinal System (K170964)Medyssey USA, Inc.2017-04-26
The Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems (K170942)Choicespine, LP2017-04-26
Fortress™ Pedicular Fixation System (K170268)Spineology, Inc.2017-04-14
Threshold™ V2 Pedicular Fixation System (K170255)Spineology, Inc.2017-04-14
Palisade™ Pedicular Fixation System (K170266)Spineology, Inc.2017-04-14
Threshold™ Pedicular Fixation System (K170251)Spineology, Inc.2017-04-14
SurgTech Thoracolumbosacral (TLS) Posterior Fixation System (K163363)Surgtech, Inc.2017-04-05
CD HORIZON™ Fenestrated Screw Set (K170347)Medtronic Sofamor Danek USA2017-04-04
GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System (K163096)Gpc Medical Limited2017-03-31
Ibis® Pedicle Screw System (K162995)Ortho Development Corporation2017-03-30
USS System (K170654)Synthes USA Products, LLC2017-03-29
Sterispine™ PS (K170528)Safe Orthopaedics2017-03-09
SeaSpine® Daytona® Small Stature Spinal System (K163604)SeaSpine Orthopedics Corporation2017-03-09
NuVasive® Reline® 4.5-5.0 System (K170126)Nu Vasive, Incorporated2017-03-09
Revolution™ Spinal Fixation System (K163056)Intelligent Implant Systems, LLC2017-02-24
Erisma® LP Spinal Fixation System (K170163)Clariance, Sas2017-02-14
Hubble I System (K163566)Orbbo Surgical, LLC2017-02-09
ProMIS™ Fixation System (K170061)Premia Spine, Ltd.2017-02-02
PASS LP Spinal System (K162786)Medicrea International SA2017-01-25
Facilis™ Spinal System (K161231)Baui Biotech Co., Ltd.2017-01-23
JAZZ FRAME SYSTEM (K162764)Implanet, S.A.2017-01-19
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