Product Code: ODP


Products Classified as ODP

4658Intervertebral Fusion Device With Bone Graft, CervicalIntervertebral Body Fusion Device.

Total Product Life Cycle (TPLC) Devices

4658Intervertebral Fusion Device With Bone Graft, CervicalIntervertebral Body Fusion Device.

FDA Consensus Standards

Intervertebral Fusion Device With Bone Graft, Cervical [37410]21 CFR §888.3080 ๐Ÿ”Ž
Intervertebral Fusion Device With Bone Graft, Cervical [37411]21 CFR §888.3080 ๐Ÿ”Ž
Intervertebral Fusion Device With Bone Graft, Cervical [38350]21 CFR §888.3080 ๐Ÿ”Ž
Intervertebral Fusion Device With Bone Graft, Cervical [37409]21 CFR §888.3080 ๐Ÿ”Ž
Intervertebral Fusion Device With Bone Graft, Cervical [37828]21 CFR §888.3080 ๐Ÿ”Ž
Intervertebral Fusion Device With Bone Graft, Cervical [38349]21 CFR §888.3080 ๐Ÿ”Ž

Pre-market Notifications for ODP

K210890GPS Cervical SpacersG Surgical LLC
K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC
K203444BEE HA CageNGMedical GmbH
K203342CONSTRUX Mini Ti Spacer SystemOrthofix Inc.
K202949CONSTRUX Mini PEEK Spacer SystemOrthofix Inc.
K202872Prase PEEK Anterior Cervical Interbody SpacerGBS Commonwealth Co., Ltd.
K202666CONSTRUX Mini PTC Spacer SystemOrthofix Inc.
K202488ZSFab Cervical Interbody SystemZSFab Inc.
K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC
K202302Atlas Spine Rebar (Ti) Spacer SystemAtlas Spine, Inc.
K201769Cavetto [MAX] Cervical Cage SystemNeuroStructures, Inc.
K201506Talosยฎ-C Cervical Intervertebral Body Fusion System, Talosยฎ-C (HA) Cervical Intervertebral Body Fusion SystemMeditech Spine, LLC
K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC
K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC
K200429BEE CagesNGMedical GmbH

Global Unique Device Identification Database

00613994646019Intervertebral fusion device with bone graft, cervical
00613994646002Intervertebral fusion device with bone graft, cervical
00613994645999Intervertebral fusion device with bone graft, cervical
00613994645982Intervertebral fusion device with bone graft, cervical
00613994645975Intervertebral fusion device with bone graft, cervical
00613994645777Intervertebral fusion device with bone graft, cervical
00613994645760Intervertebral fusion device with bone graft, cervical
00613994645753Intervertebral fusion device with bone graft, cervical
00613994645746Intervertebral fusion device with bone graft, cervical
00613994645739Intervertebral fusion device with bone graft, cervical
00613994504470Intervertebral fusion device with bone graft, cervical
00613994503442Intervertebral fusion device with bone graft, cervical
00613994503435Intervertebral fusion device with bone graft, cervical
00613994503428Intervertebral fusion device with bone graft, cervical
00613994503411Intervertebral fusion device with bone graft, cervical

Maude Adverse Events

CAVUX CERVICAL CAGE-BPROVIDENCE MEDICAL TECHNOLOGY, INC.2020-03-31
ACIS CAGE STD LORDOTIC H7OBERDORF SYNTHES PRODUKTIONS GMBH2020-03-17
ACIS CAGE STD LORDOTIC H6OBERDORF SYNTHES PRODUKTIONS GMBH2020-03-17
ACIS CAGE STD LORDOTIC H7OBERDORF SYNTHES PRODUKTIONS GMBH2020-03-17
AERO C CAGE 5MM INTERBODY DEVICE, 12DX14W PARALLELSTRYKER SPINE-US2020-03-14
COMPLETE CERVICAL STAND ALONE IBDSEASPINE INC.2020-02-25
UNK - CAGE/SPACERS: CERVIOSOBERDORF SYNTHES PRODUKTIONS GMBH2020-02-06
UNK - PLATES: ANTERIOR CERVICAL LOCKING PLATEOBERDORF SYNTHES PRODUKTIONS GMBH2020-02-06
UNK - CAGE/SPACERS: SYNCAGEOBERDORF SYNTHES PRODUKTIONS GMBH2020-02-06
CAVUX CERVICAL CAGE-SBPROVIDENCE MEDICAL TECHNOLOGY, INC.2020-01-27
UNKNOWN BIOMATERIAL - PREFORMEDDEPUY SPINE INC2020-01-23
VALEO AND VALEO IISINTX TECHNOLOGIES (FORMERLY AMEDICA CORP)2020-01-21
IMPLANT ROI-C 12X14 H6LDR MEDICAL2019-11-27
IMPLANT ROI-C 12X14 H5LDR MEDICAL2019-11-26
MECTA C CAGE 15X 18X 7MM/ MECTA C CAGE 15X18MEDACTA INTERNATIONAL SA2019-11-22
IMPLANT ROI-C 12X15,5 H5LDR MEDICAL2019-11-15
IMPLANT ROI-C 12X14 H4,5LDR MEDICAL2019-11-14
IMPLANT ROI-C 12X14 H6LDR MEDICAL2019-11-14
IMPLANT ROI-C 14X17 H7LDR MEDICAL2019-11-06
UNK - PLATES: SPINEOBERDORF SYNTHES PRODUKTIONS GMBH2019-11-04
UNK - PLATES: SPINEOBERDORF SYNTHES PRODUKTIONS GMBH2019-11-04
UNK - PLATES: SPINEOBERDORF SYNTHES PRODUKTIONS GMBH2019-11-04
UNK - PLATES: SPINEOBERDORF SYNTHES PRODUKTIONS GMBH2019-11-04
UNK - PLATES: SPINEOBERDORF SYNTHES PRODUKTIONS GMBH2019-11-04
UNK - PLATES: SPINEOBERDORF SYNTHES PRODUKTIONS GMBH2019-11-04
UNK - PLATES: SPINEOBERDORF SYNTHES PRODUKTIONS GMBH2019-11-04
VERTEBRAL SPACER-CR LORDOTIC 6MM HEIGHTOBERDORF SYNTHES PRODUKTIONS GMBH2019-10-31
TI VECTRA-ONE PLATE 2 LEVEL/36MMWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-10-30
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICALCHOICE SPINE, LP2019-10-29
IMPLANT ROI-C 12X14 H6LDR MEDICAL2019-10-27
CAVUX CERVICAL CAGE-B 5MMPROVIDENCE MEDICAL TECHNOLOGY, INC.2019-10-21
NUVASIVE MODULUS-C INTERBODY SYSTEMNUVASIVE2019-10-21
NUBICSIGNUS MEDIZINTECHNIK GMBH2019-10-15
UNK - PLATES: SPINEOBERDORF SYNTHES PRODUKTIONS GMBH2019-10-03
UNK - PLATES: SPINEOBERDORF SYNTHES PRODUKTIONS GMBH2019-10-03
UNK - PLATES: SPINEOBERDORF SYNTHES PRODUKTIONS GMBH2019-10-03
UNK - PLATES: SPINEOBERDORF SYNTHES PRODUKTIONS GMBH2019-10-03
CAVUX CERVICAL CAGE-TPROVIDENCE MEDICAL TECHNOLOGY, INC.2019-10-02
CAVUX CERVICAL CAGE-TPROVIDENCE MEDICAL TECHNOLOGY, INC.2019-10-02
CAVUX CERVICAL CAGE-TPROVIDENCE MEDICAL TECHNOLOGY, INC.2019-10-02
CAVUX CERVICAL CAGE-TPROVIDENCE MEDICAL TECHNOLOGY, INC.2019-10-02
CAVUX CERVICAL CAGE-B 4MMPROVIDENCE MEDICAL TECHNOLOGY, INC.2019-10-02
UNK - PLATES: SPINEWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-10-02
UNK - PLATES: SPINEWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-10-02
UNK - PLATES: SPINEWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-10-02
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICALOBERDORF SYNTHES PRODUKTIONS GMBH2019-09-26
UNK - PLATES: SPINEOBERDORF SYNTHES PRODUKTIONS GMBH2019-09-25
UNK - PLATES: SPINEOBERDORF SYNTHES PRODUKTIONS GMBH2019-09-25
UNK - PLATES: SPINEOBERDORF SYNTHES PRODUKTIONS GMBH2019-09-25
UNK - PLATES: SPINEOBERDORF SYNTHES PRODUKTIONS GMBH2019-09-24

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