Product Code: KWQ


Products Classified as KWQ

4575Appliance, Fixation, Spinal Intervertebral BodySpinal Intervertebral Body Fixation Orthosis.

Total Product Life Cycle (TPLC) Devices

4575Appliance, Fixation, Spinal Intervertebral BodySpinal Intervertebral Body Fixation Orthosis.

FDA Consensus Standards

Appliance, Fixation, Spinal Intervertebral Body [37410]21 CFR §888.3060 🔎
Appliance, Fixation, Spinal Intervertebral Body [37411]21 CFR §888.3060 🔎
Appliance, Fixation, Spinal Intervertebral Body [37829]21 CFR §888.3060 🔎
Appliance, Fixation, Spinal Intervertebral Body [37437]21 CFR §888.3060 🔎
Appliance, Fixation, Spinal Intervertebral Body [38313]21 CFR §888.3060 🔎
Appliance, Fixation, Spinal Intervertebral Body [38312]21 CFR §888.3060 🔎
Appliance, Fixation, Spinal Intervertebral Body [32387]21 CFR §888.3060 🔎

Pre-market Notifications for KWQ

K222628Life Spine ALIF Buttress Plate SystemLife Spine, Inc.
K222493CODA™ Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.,
K221728Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating (ACP) System, Reflex™ Hybrid ACP System, UniVise™ Spinous Process Fixation PlateStryker Corporation
K220843OAKTREE Anterior Lumbar Plate And Screw SystemOak Tree Engineering, LLC.
K220441CYGNUS™ MoRe Anterior Cervical Plate SystemMiRus, LLC
K220379IMPEACE And IMPEACE-Uni Anterior Cervical Plate SystemMedynus Inc.
K220334MONET Anterior Cervical Plate SystemCTL Medical Corporation
K220324AccuFit Lateral 2-Hole PlatePrecision Spine, Inc.
K220275EMERGE Anterior Cervical Plate SystemEvolution Spine
K220182Aggeris™-CClariance
K220147Aspiron S ACP SystemU&I Corporation
K213901Cyclops™ Anterior Cervical Plate SystemDeGen Medical
K213820BALTEUM - ONE™ Lumbar Plate SystemHuvexel Co., Ltd
K213443Insignia™ Anterior Cervical Plate SystemAlphatec Spine, Inc.
K213219Vy Spine™ VyWasher™ Buttress SystemVy Spine, LLC

Global Unique Device Identification Database

00193082052507Appliance, fixation, spinal intervertebral body
00613994953124APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
00613994953117APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
00613994950871APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
00613994950635APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
00613994950628APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
00613994950543APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
00613994950529APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
00613994950482APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
00613994950468APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
00613994950437APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
00613994950314APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
00613994950246APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
00613994950239APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
00613994950161APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Maude Adverse Events

UNKNOWN_K2M_PRODUCTK2M, INC.2020-03-27
QUINTEX SEMICONSTRAINED SCREW 4.0X18MMAESCULAP AG2020-03-27
NUVASIVE HELIX REVOLUTION ACP SYSTEMNUVASIVE INC2020-03-24
NUVASIVE HELIX REVOLUTION ACP SYSTEMNUVASIVE INC2020-03-24
SPINE CERVICAL SCREWNUVASIVE, INC.2020-03-20
HEX SCREWS AND 4MM X 1500NUVASIVE, INC.2020-03-20
NUVASIVE PLATE MINI HELIX SPINE, 4MM X 15MMNUVASIVE, INC.2020-03-20
NUVASIVE HELIX REVOLUTION ACP SYSTEMNUVASIVE INC.2020-03-19
SELF-STARTING, VARIABLE SCREW; SIZE ?4.0X16 MMK2M, INC.2020-03-19
SELF-STARTING, VARIABLE SCREW; SIZE ?4.0X16 MMK2M, INC.2020-03-19
SELF-STARTING, VARIABLE SCREW; SIZE ?4.0X16 MMK2M, INC.2020-03-19
SELF-STARTING, VARIABLE SCREW; SIZE ?4.0X16 MMK2M, INC.2020-03-19
UNKNOWN_K2M_PRODUCTK2M, INC.2020-03-18
SELF-STARTING, VARIABLE SCREW; SIZE ?4.0X14 MMK2M, INC.2020-03-18
SELF-STARTING, VARIABLE SCREW; SIZE ?4.0X14 MMK2M, INC.2020-03-18
SELF-STARTING, VARIABLE SCREW; SIZE ?4.0X16 MMK2M, INC.2020-03-18
UNKNOWN_K2M_PRODUCTK2M, INC.2020-03-18
UNKNOWN_K2M_PRODUCTK2M, INC.2020-03-18
SELF-STARTING, VARIABLE SCREW; SIZE ?4.0X16 MMK2M, INC.2020-03-18
ZEVO ANTERIOR CERVICAL PLATE SYSTEMMDT SOFAMOR DANEK PUERTO RICO MFG2020-03-17
ZEVO ANTERIOR CERVICAL PLATE SYSTEMMDT SOFAMOR DANEK PUERTO RICO MFG2020-03-17
UNKNOWN_K2M_PRODUCTK2M, INC.2020-03-17
UNKNOWN_K2M_PRODUCTK2M, INC.2020-03-16
UNKNOWN_K2M_PRODUCTK2M, INC.2020-03-16
UNKNOWN_K2M_PRODUCTK2M, INC.2020-03-16
UNKNOWN_K2M_PRODUCTK2M, INC.2020-03-16
EXPEDIUM VERSE SPINE SYSTEM VERSE CORRECTION KEY 5.5MEDOS INTERNATIONAL SàRL CH2020-03-13
EXPEDIUM VERSE SPINE SYSTEM VERSE CORRECTION KEY 5.5MEDOS INTERNATIONAL SàRL CH2020-03-13
EXPEDIUM VERSE SPINE SYSTEM VERSE CORRECTION KEY 5.5MEDOS INTERNATIONAL SàRL CH2020-03-13
VERSE CORRECTION KEYMEDOS INTERNATIONAL SàRL CH2020-03-13
EXPEDIUM VERSE SPINE SYSTEM VERSE CORRECTION KEY 5.5MEDOS INTERNATIONAL SàRL CH2020-03-13
EXPEDIUM VERSE SPINE SYSTEM VERSE CORRECTION KEY 5.5MEDOS INTERNATIONAL SàRL CH2020-03-13
EXPEDIUM VERSE SPINE SYSTEM VERSE CORRECTION KEY 5.5MEDOS INTERNATIONAL SàRL CH2020-03-13
EXPEDIUM VERSE SPINE SYSTEM VERSE CORRECTION KEY 5.5MEDOS INTERNATIONAL SàRL CH2020-03-13
COLLECT.NO.QAS SPINE CERVICAL STABILIS.AESCULAP AG2020-03-11
STAPLE, 24 MMMEDOS INTERNATIONAL SàRL CH2020-03-10
ANTI BACKOUT SCREW, 25 MMMEDOS INTERNATIONAL SàRL CH2020-03-10
STAPLE, 24 MMMEDOS INTERNATIONAL SàRL CH2020-03-10
ANTI BACKOUT SCREW, 20 MMMEDOS INTERNATIONAL SàRL CH2020-03-10
5.5 TI CORT FIX 6X50MMMEDOS INTERNATIONAL SàRL CH2020-03-09
ATLANTIS TRANSLATIONAL SPINAL SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC.2020-03-09
MEDTRONIC SOFAMOR DANEK USA, INC.2020-03-06
CONSTRAINED PLATE, 3 LEVEL; SIZE 60 MMK2M, INC.2020-03-06
QUINTEX SEMICONSTRAINED SCREW 4.0X16MMAESCULAP AG2020-03-05
QUINTEX SEMICONSTRAINED SCREW 4.0X16MMAESCULAP AG2020-03-05
EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 X 6 X 40MMMEDOS INTERNATIONAL SàRL CH2020-03-05
FALCON CERVICAL PLATE SYSTEMCHOICESPINE, LLC2020-03-03
ZEVO ANTERIOR CERVICAL PLATE SYSTEMMEDTRONIC SOFAMOR DANEK USA, INC.2020-02-28
TI SNAP-ON TRANSCONNECTOR 30MM-33MM FOR 5.5MM/6.0MM RODSOBERDORF SYNTHES PRODUKTIONS GMBH2020-02-28
ASPIRON ACP SYSTEMU&I CORPORATION2020-02-28

© 2023 FDA.report
This site is not affiliated with or endorsed by the FDA.