Panels › Orthopedic › Product code ODP · Class 2
Intervertebral Fusion Device With Bone Graft, Cervical
Regulation 888.3080
24510(k)s in 12 months (354 all time)
2recalls in 12 months (11 all time)
9recalls that name a 510(k)
Top companies in ODP
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 7, 2016 | K160222 | OIC Cervical PEEK Spacer The Orthopaedic Implant Company | ODP |
| Dec 6, 2016 | K161809 | ShurFit CpTi-HA ACIF Interbody Fusion System Precision Spine, Inc. | ODP |
| Nov 21, 2016 | K162220 | DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage Dio Medical Co., Ltd., KR | ODP |
| Nov 9, 2016 | K161649 | Virtu C Spinal Implant System Met 1 Technologies, LLC | ODP |
| Oct 26, 2016 | K162138 | NuVasive CoRoent Small Ti-C System Nu Vasive, Incorporated | ODP |
| Oct 7, 2016 | K161642 | CAVUX Cervical Cage Providence Medical Technology, Inc. | ODP |
| Sep 30, 2016 | K161608 | InterForm Cervical Interbody Cage System Next Orthosurgical | ODP |
| Jul 15, 2016 | K161407 | Ascential IBD PEEKc Spacer Stryker Spine | ODP |
| Jun 24, 2016 | K153517 | AnyPlus® Cervical PEEK Cage System GS Medical Co., Ltd., KR | ODP |
| May 13, 2016 | K160154 | ALTA Anterior Cervical Interbody Spacer Astura Medical | ODP |
| May 5, 2016 | K160324 | Cervical Interbody Fusion System Evolution Spine, LLC | ODP |
| Apr 22, 2016 | K160125 | Cascadia Interbody System K2m | ODP |
| Mar 28, 2016 | K160528 | ANATOMIC PEEK PTC Cervical Fusion System Medtronic Sofamor Danek USA, Inc. | ODP |
| Mar 2, 2016 | K153438 | PERIMETER C (Titanium) Spinal System Medtronic Sofamor Danek USA, Inc. | ODP |
| Jan 19, 2016 | K153373 | CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device Medtronic Sofamor Danek | ODP |
| Dec 18, 2015 | K152532 | AERO -C Cervical Cage System Stryker Spine | ODP |
| Dec 15, 2015 | K151496 | Latitude-C Cervical Interbody Spacer System Degen Medical | ODP |
| Dec 11, 2015 | K152987 | Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody System Xenco Medical, LLC | ODP |
| Nov 19, 2015 | K150455 | RT2 Trabeculite Titanium Cervical Cage System Rhausler, Inc. | ODP |
| Oct 14, 2015 | K150788 | Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C(HA) Cervical In Meditech Spine, LLC | ODP |
| Sep 23, 2015 | K143685 | Hedgehog Cervical Interbody Fusion Device Vertera, Inc. | ODP |
| Sep 16, 2015 | K143450 | Ackermann Intervertebral Body Fusion Device Ackermann Instrumente GmbH, DE | ODP |
| Sep 11, 2015 | K150619 | CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System Orthofix, Inc. | ODP |
| Sep 10, 2015 | K152302 | Xenco Medical Cervical Interbody System (Argus) Xenco Medical, LLC | ODP |
| Sep 3, 2015 | K150812 | Genesys Spine Apache Cervical Interbody Fusion System Genesys Spine | ODP |
| Aug 13, 2015 | K150847 | Foundation Interbody Devices Corelink, LLC | ODP |
| Jul 15, 2015 | K151677 | LnK Cervical Interbody Fusion Cage System L&K BIOMED Co., Ltd., KR | ODP |
| Jun 11, 2015 | K150362 | NuVasive CoRoent Small Interbody System Nu Vasive, Incorporated | ODP |
| Jun 10, 2015 | K143572 | Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomat Osteomed Implantes, Ltda, BR | ODP |
| Jun 9, 2015 | K142269 | Reliance Cervical IBF System Reliance Medical Systems, LLC | ODP |
| May 28, 2015 | K150130 | Ascendant TM Cervical Spacer System Exactech, Inc. | ODP |
| May 28, 2015 | K142586 | Captiva Spine FuselOX Cervical IBF System Captiva Spine | ODP |
| May 15, 2015 | K150521 | Interbody Fusion (IBF)/Vertebral Body Replacement(VBR) System Rti Surgical, Inc. Dba Rti Biologics | ODP |
| May 7, 2015 | K142744 | Mecta-C TiPEEK Medacta International, CH | ODP |
| Apr 10, 2015 | K142456 | GPS Spacers G Surgical, LLC | ODP |
| Apr 3, 2015 | K143360 | LnK Cervical Interbody Fusion Cage System L&K BIOMED Co., Ltd., KR | ODP |
| Mar 31, 2015 | K142218 | Coalition AGX Plate and Coalition AGX Spacer Globus Medical, Inc. | ODP |
| Feb 22, 2015 | K142345 | Talos-C(HA) Cervical Intervertebral Body Fusion Devices Meditech Spine, LLC | ODP |
| Jan 8, 2015 | K142152 | CONSTRUX MINI PEEK; SPACER SYSTEM, TI SPACER SYSTEM, CERVICAL STAND ALONE SYSTEM Orthofix, Inc. | ODP |
| Dec 23, 2014 | K142328 | nvc Nvision Biomedical Technologies, LLC | ODP |
| Dec 19, 2014 | K142041 | POROSTEON PHUSION METAL CERVICAL CAGE Porosteon, Inc., CA | ODP |
| Dec 8, 2014 | K142264 | Valeo C Spacer System, Valeo II C IBF Device Amedica Corp. | ODP |
| Nov 25, 2014 | K141333 | ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE Spinefrontier, Inc. | ODP |
| Nov 19, 2014 | K142251 | AVS AS PEEK Spacer Stryker Corporation | ODP |
| Oct 29, 2014 | K142050 | NUVASIVE COROENT SMALL CONTOURED INTERBODY SYSTEM Nu Vasive, Incorporated | ODP |
| Oct 20, 2014 | K142026 | SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE Spinefrontier, Inc. | ODP |
| Oct 1, 2014 | K142450 | DIVERGENCE Anterior Cervical Fusion System Medtronic Sofamor Danek USA, Inc. | ODP |
| Sep 8, 2014 | K141337 | ARENA-C Spinefrontier, Inc. | ODP |
| Sep 5, 2014 | K140280 | FORTICORE Nanovis, LLC | ODP |
| Sep 3, 2014 | K140786 | XENCO MEDICAL CERVICAL INTERBODY SYSTEM Xenco Medical, LLC | ODP |
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