OVD

Product Code: OVD


Products Classified as OVD

4671Intervertebral Fusion Device With Integrated Fixation, LumbarIntervertebral Body Fusion Device.

Total Product Life Cycle (TPLC) Devices

4671Intervertebral Fusion Device With Integrated Fixation, LumbarIntervertebral Body Fusion Device.

FDA Consensus Standards

Intervertebral Fusion Device With Integrated Fixation, Lumbar [38350]21 CFR §888.3080 🔎
Intervertebral Fusion Device With Integrated Fixation, Lumbar [37409]21 CFR §888.3080 🔎
Intervertebral Fusion Device With Integrated Fixation, Lumbar [37828]21 CFR §888.3080 🔎
Intervertebral Fusion Device With Integrated Fixation, Lumbar [38349]21 CFR §888.3080 🔎

Pre-market Notifications for OVD

K222561AlignAcuity Surgical Devices, LLC
K221751NuVasive Cohere ALIF System Intervertebral Body Fusion DeviceNuVasive, Incorporated
K221545MectaLIF Anterior ExtensionMedacta International S.A.
K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty) Ltd
K220610SOLO-LAurora Spine Inc
K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC
K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical
K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems
K213118Dakota ALIF SystemPrecision Spine, Inc.
K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.
K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.
K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC
K211769OneLIF Intervertebral Body Replacement SystemNovApproach Spine
K210590Axis Spine Technologies ALIFAxis Spine Technologies Ltd
K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine Inc.

Global Unique Device Identification Database

00613994736611Intervertebral fusion device with integrated fixation, lumbar
00613994736598Intervertebral fusion device with integrated fixation, lumbar
00613994736574Intervertebral fusion device with integrated fixation, lumbar
00613994736550Intervertebral fusion device with integrated fixation, lumbar
00613994736536Intervertebral fusion device with integrated fixation, lumbar
00613994736512Intervertebral fusion device with integrated fixation, lumbar
00613994736499Intervertebral fusion device with integrated fixation, lumbar
00613994736475Intervertebral fusion device with integrated fixation, lumbar
00643169794665Intervertebral fusion device with integrated fixation, lumbar
00643169794658Intervertebral fusion device with integrated fixation, lumbar
00643169721517Intervertebral fusion device with integrated fixation, lumbar
00643169704039Intervertebral fusion device with integrated fixation, lumbar
00643169702950Intervertebral fusion device with integrated fixation, lumbar
00643169659544Intervertebral fusion device with integrated fixation, lumbar
00643169659537Intervertebral fusion device with integrated fixation, lumbar

Maude Adverse Events

UNK - CAGE/SPACERS: SYNCAGEOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
UNK - CAGE/SPACERS: SYNCAGEOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
NUVASIVE BASE INTERFIXATED TITANIUM SYSTEMNUVASIVE, INCORPORATED2020-03-27
NUVASIVE BASE INTERFIXATED TITANIUM SYSTEMNUVASIVE, INCORPORATED2020-03-27
NUVASIVE BASE INTERFIXATED TITANIUM SYSTEMNUVASIVE, INCORPORATED2020-03-27
NUVASIVE BASE INTERFIXATED TITANIUM SYSTEMNUVASIVE, INCORPORATED2020-03-27
NUVASIVE BASE INTERFIXATED TITANIUM SYSTEMNUVASIVE, INCORPORATED2020-03-26
NUVASIVE BASE INTERFIXATED TITANIUM SYSTEMNUVASIVE, INCORPORATED2020-03-26
NUVASIVE BASE INTERFIXATED TITANIUM SYSTEMNUVASIVE, INCORPORATED2020-03-26
NUVASIVE BASE INTERFIXATED TITANIUM SYSTEMNUVASIVE, INCORPORATED2020-03-26
NUVASIVE BASE INTERFIXATED TITANIUM SYSTEMNUVASIVE, INCORPORATED2020-03-26
NUVASIVE BASE INTERFIXATED TITANIUM SYSTEMNUVASIVE, INCORPORATED2020-03-25
SYNFIX? EVOLUTION SPACERLARGE/13.5MM HEIGHT/14?-STEROBERDORF SYNTHES PRODUKTIONS GMBH2020-03-25
NUVASIVE BASE INTERFIXATED TITANIUM SYSTEMNUVASIVE, INCORPORATED2020-03-24
UNK - CAGE/SPACERS: ORACLEOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-23
NUVASIVE BASE INTERFIXATED TITANIUM SYSTEMNUVASIVE, INCORPORATED2020-03-17
ENDOSKELETON? TAS NANOLOCK? SURFACE TECHNOLOGYTITAN SPINE2020-03-12
UNKNOWN CAGE/SPACERMEDOS INTERNATIONAL SàRL CH2020-03-10
UNKNOWN CAGE/SPACERMEDOS INTERNATIONAL SàRL CH2020-03-05
UNKNOWN CAGE/SPACERMEDOS INTERNATIONAL SàRL CH2020-03-05
UNK - CAGE/SPACERSWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-02-28
UNK - CAGE/SPACERSWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-02-28
UNK - CAGE/SPACERSWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-02-28
UNK - CAGE/SPACERSWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-02-28
UNK - CAGE/SPACERSWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-02-28
UNK - CAGE/SPACERSWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-02-28
UNK - CAGE/SPACERSWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-02-28
UNK - CAGE/SPACERSWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-02-28
UNK - CAGE/SPACERSWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-02-28
UNK - CAGE/SPACERSWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-02-28
UNK - CAGE/SPACERS: SYNCAGEOBERDORF SYNTHES PRODUKTIONS GMBH2020-02-25
STALIF M FLX CAGE 36MM X 13MM X 16DEGCENTINEL SPINE, LLC.2020-02-19
STALIF MIDLINE ABO REVISION SCREW 6.0MM X 25MMCENTINEL SPINE, LLC.2020-02-19
STALIF MIDLINE ABO SCREW 6.0MM X 25MMCENTINEL SPINE, LLC.2020-02-19
STALIF MIDLINE ABO SCREW 6.0MM X 25MMCENTINEL SPINE, LLC.2020-02-19
M3 STAND-ALONE ANTERIOR LUMBAR SYSTEMCORELINK SURGICAL, LLC2020-02-19
UNKNOWN CAGE/SPACERMEDOS INTERNATIONAL SàRL CH2020-02-10
UNKNOWN CAGE/SPACERMEDOS INTERNATIONAL SàRL CH2020-02-07
IRIX-A LUMBAR INTEGRATED FUSION SYSTEMX-SPINE SYSTEMS, INC.2020-02-04
UNK - CAGE/SPACERS: SYNCAGEOBERDORF SYNTHES PRODUKTIONS GMBH2020-02-03
UNK - CAGE/SPACERS: SYNCAGEOBERDORF SYNTHES PRODUKTIONS GMBH2020-02-03
UNK - CAGE/SPACERS: PLIVIOSOBERDORF SYNTHES PRODUKTIONS GMBH2020-01-31
UNK - CAGE/SPACERS: OPALOBERDORF SYNTHES PRODUKTIONS GMBH2020-01-31
UNK - CAGE/SPACERSOBERDORF SYNTHES PRODUKTIONS GMBH2020-01-31
UNK - CAGE/SPACERS: PLIVIOSOBERDORF SYNTHES PRODUKTIONS GMBH2020-01-31
UNK - CAGE/SPACERS: OPALOBERDORF SYNTHES PRODUKTIONS GMBH2020-01-31
UNK - CAGE/SPACERS: OPALOBERDORF SYNTHES PRODUKTIONS GMBH2020-01-29
UNK - CAGE/SPACERS: OPALOBERDORF SYNTHES PRODUKTIONS GMBH2020-01-29
UNK - CAGE/SPACERS/BIOWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-01-27
UNK - CAGE/SPACERS/BIOWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-01-27
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