Product Code: OVE


Products Classified as OVE

4672Intervertebral Fusion Device With Integrated Fixation, CervicalIntervertebral Body Fusion Device.

Total Product Life Cycle (TPLC) Devices

4672Intervertebral Fusion Device With Integrated Fixation, CervicalIntervertebral Body Fusion Device.

FDA Consensus Standards

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

Pre-market Notifications for OVE

K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation
K212853Cervical Stand-Alone SystemEminent Spine, LLC
K212562Idys-C ZP 3DTiClariance, SA
K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc
K210573Velofix SA Cervical CageU&I Corporation
K210470C-CURVE Interbody Fusion DeviceMedicrea International S. A.
K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC
K203129NexGen Standalone Anterior Cervical Discectomy And Fusion (ACDF) SystemPrecision Spine, Inc.
K203076Mecta-C Stand Alone ExtensionMedacta International SA
K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.
K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation
K201073Seaspine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation
K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine LLC
K200115Cavetto-SA Cervical Cage SystemNeuroStructures, Inc.
K200087F3D Cervical Stand-Alone Interbody Fusion SystemCoreLink, LLC

Global Unique Device Identification Database

00613994853264Intervertebral fusion device with integrated fixation, cervical
00613994753922Intervertebral fusion device with integrated fixation, cervical
00643169363458Intervertebral fusion device with integrated fixation, cervical
00643169363182Intervertebral fusion device with integrated fixation, cervical
00643169363175Intervertebral fusion device with integrated fixation, cervical
00643169363168Intervertebral fusion device with integrated fixation, cervical
00643169363151Intervertebral fusion device with integrated fixation, cervical
00643169363144Intervertebral fusion device with integrated fixation, cervical
00643169363137Intervertebral fusion device with integrated fixation, cervical
00643169363120Intervertebral fusion device with integrated fixation, cervical
00643169363113Intervertebral fusion device with integrated fixation, cervical
00643169363106Intervertebral fusion device with integrated fixation, cervical
00643169363090Intervertebral fusion device with integrated fixation, cervical
00643169363083Intervertebral fusion device with integrated fixation, cervical
00643169363076Intervertebral fusion device with integrated fixation, cervical

Maude Adverse Events

IMPLANT ROI-C LORDOSELDR MEDICAL2020-03-27
ROI-C IMPLANT 14X14 H6LDR MEDICAL2020-03-24
ENDOSKELETON? TCSTITAN SPINE2020-03-10
DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEMMDT SOFAMOR DANEK PUERTO RICO MFG2020-03-09
DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEMMDT SOFAMOR DANEK PUERTO RICO MFG2020-03-09
ROI-C SHORT ANCHORING PLATELDR MEDICAL2020-03-05
ROI-C LONG ANCHORING PLATELDR MEDICAL2020-03-04
IMPLANT ROI-C LORDOSELDR MEDICAL2020-03-04
ENDOSKELETON? TCSTITAN SPINE2020-02-27
ZERO-P IMPLANT 6MM HEIGHT LORDOTIC-STERILEOBERDORF SYNTHES PRODUKTIONS GMBH2020-02-26
SHORELINE ACS ANTERIOR CERVICAL STANDALONE SYSTEMSEASPINE INC.2020-02-21
SHORELINE ACS ANTERIOR CERVICAL STANDALONE SYSTEMSEASPINE INC.2020-02-21
ROI-C SHORT ANCHORING PLATELDR MEDICAL2020-02-19
ROI-C LORDOTIC COATED IMPLANT 12 X14 H8LDR MEDICAL2020-02-19
DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEMMDT SOFAMOR DANEK PUERTO RICO MFG2020-02-18
UNK - SCREWS: ZERO-POBERDORF SYNTHES PRODUKTIONS GMBH2020-02-11
UNK - CAGE/PLATE: ZERO-POBERDORF SYNTHES PRODUKTIONS GMBH2020-02-11
ZERO-P IMPLANT 6MM HEIGHT CONVEX-STERILEOBERDORF SYNTHES PRODUKTIONS GMBH2020-02-07
ZERO-P IMPLANT 6MM HEIGHT CONVEX-STERILEOBERDORF SYNTHES PRODUKTIONS GMBH2020-02-07
ZERO-P VA IMPLANT 5MM HEIGHT LORDOTIC-STERILEOBERDORF SYNTHES PRODUKTIONS GMBH2020-02-07
UNK - CAGE/SPACERS: SYNCAGEOBERDORF SYNTHES PRODUKTIONS GMBH2020-02-06
ROI-C IMPLANT, UNKNOWN SIZELDR MEDICAL2020-02-04
UNKNOWN TRIALSDEPUY SPINE INC2020-01-24
ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAININGOBERDORF SYNTHES PRODUKTIONS GMBH2020-01-23
COROENT INTERLOCK SYSTEMNUVASIVE, INC.2020-01-23
BLACKHAWK CERVICAL SPACER SYSTEMCHOICESPINE, LP2020-01-20
BLACKHAWK CERVICAL SPACER SYSTEMCHOICESPINE, LLC2020-01-14
ROI-C LONG ANCHORING PLATELDR MEDICAL2020-01-12
ROI-C SHORT ANCHORING PLATELDR MEDICAL2020-01-09
ZERO-P CONVEX H6 PEEKOBERDORF SYNTHES PRODUKTIONS GMBH2020-01-08
ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAININGOBERDORF SYNTHES PRODUKTIONS GMBH2020-01-07
ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAININGOBERDORF SYNTHES PRODUKTIONS GMBH2020-01-07
ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAININGOBERDORF SYNTHES PRODUKTIONS GMBH2020-01-07
ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAININGOBERDORF SYNTHES PRODUKTIONS GMBH2020-01-07
ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAININGOBERDORF SYNTHES PRODUKTIONS GMBH2020-01-07
ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAININGOBERDORF SYNTHES PRODUKTIONS GMBH2020-01-07
ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAININGOBERDORF SYNTHES PRODUKTIONS GMBH2020-01-07
ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAININGOBERDORF SYNTHES PRODUKTIONS GMBH2020-01-07
ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAININGOBERDORF SYNTHES PRODUKTIONS GMBH2020-01-07
ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING.OBERDORF SYNTHES PRODUKTIONS GMBH2020-01-07
IMPLANT ROI-C REVETULDR MEDICAL2020-01-02
DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEMMDT SOFAMOR DANEK PUERTO RICO MFG2020-01-02
ROI-C LONG ANCHORING PLATELDR MEDICAL2019-11-27
KYOCERA TESERA SC STAND ALONE CERVICAL CAGEKYOCERA MEDICAL TECHNOLOGIES, INC2019-11-26
2.5MM AWL WITH SLEEVE VARIABLE ANGLEWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-11-26
ROI-C SHORT ANCHORING PLATELDR MEDICAL2019-11-22
IMPLANT ROI-C REVETULDR MEDICAL2019-11-22
ROI-C SHORT ANCHORING PLATELDR M?DICAL2019-11-22
ROI-C LORDOTIC COATED IMPLANT 12 X14 H7LDR MEDICAL2019-11-15
ZERO-P VA IMPLANT 6MM HEIGHT CONVEX/LARGE-STERILEWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-11-12

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.