FDA Product Code
FDA Product Code ODP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3080
510(k) Clearances — 354 records · page 3 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K160222 | OIC Cervical PEEK Spacer | The Orthopaedic Implant Company | 2016-12-07 | Traditional | PDF ↗ |
| K161809 | ShurFit CpTi-HA ACIF Interbody Fusion System | Precision Spine, Inc. | 2016-12-06 | Traditional | PDF ↗ |
| K162220 | DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage | Dio Medical Co., Ltd. | 2016-11-21 | Traditional | PDF ↗ |
| K161649 | Virtu C Spinal Implant System | Met 1 Technologies, LLC | 2016-11-09 | Traditional | PDF ↗ |
| K162138 | NuVasive CoRoent Small Ti-C System | Nu Vasive, Incorporated | 2016-10-26 | Traditional | PDF ↗ |
| K161642 | CAVUX Cervical Cage | Providence Medical Technology, Inc. | 2016-10-07 | Traditional | PDF ↗ |
| K161608 | InterForm Cervical Interbody Cage System | Next Orthosurgical | 2016-09-30 | Traditional | PDF ↗ |
| K161407 | Ascential IBD PEEKc Spacer | Stryker Spine | 2016-07-15 | Special | PDF ↗ |
| K153517 | AnyPlus® Cervical PEEK Cage System | GS Medical Co., Ltd. | 2016-06-24 | Traditional | PDF ↗ |
| K160154 | ALTA Anterior Cervical Interbody Spacer | Astura Medical | 2016-05-13 | Traditional | PDF ↗ |
| K160324 | Cervical Interbody Fusion System | Evolution Spine, LLC | 2016-05-05 | Traditional | PDF ↗ |
| K160125 | Cascadia Interbody System | K2m | 2016-04-22 | Traditional | PDF ↗ |
| K160528 | ANATOMIC PEEK PTC Cervical Fusion System | Medtronic Sofamor Danek USA, Inc. | 2016-03-28 | Traditional | PDF ↗ |
| K153438 | PERIMETER C (Titanium) Spinal System | Medtronic Sofamor Danek USA, Inc. | 2016-03-02 | Special | PDF ↗ |
| K153373 | CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device | Medtronic Sofamor Danek | 2016-01-19 | Traditional | PDF ↗ |
| K152532 | AERO -C Cervical Cage System | Stryker Spine | 2015-12-18 | Traditional | PDF ↗ |
| K151496 | Latitude-C Cervical Interbody Spacer System | Degen Medical | 2015-12-15 | Traditional | PDF ↗ |
| K152987 | Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody System | Xenco Medical, LLC | 2015-12-11 | Special | PDF ↗ |
| K150455 | RT2 Trabeculite Titanium Cervical Cage System | Rhausler, Inc. | 2015-11-19 | Abbreviated | PDF ↗ |
| K150788 | Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C(HA) Cervical Intervertebral Body Fusion Devices | Meditech Spine, LLC | 2015-10-14 | Traditional | PDF ↗ |
| K143685 | Hedgehog Cervical Interbody Fusion Device | Vertera, Inc. | 2015-09-23 | Traditional | PDF ↗ |
| K143450 | Ackermann Intervertebral Body Fusion Device | Ackermann Instrumente GmbH | 2015-09-16 | Traditional | PDF ↗ |
| K150619 | CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System | Orthofix, Inc. | 2015-09-11 | Traditional | PDF ↗ |
| K152302 | Xenco Medical Cervical Interbody System (Argus) | Xenco Medical, LLC | 2015-09-10 | Special | PDF ↗ |
| K150812 | Genesys Spine Apache Cervical Interbody Fusion System | Genesys Spine | 2015-09-03 | Abbreviated | PDF ↗ |
| K150847 | Foundation Interbody Devices | Corelink, LLC | 2015-08-13 | Traditional | PDF ↗ |
| K151677 | LnK Cervical Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2015-07-15 | Special | PDF ↗ |
| K150362 | NuVasive CoRoent Small Interbody System | Nu Vasive, Incorporated | 2015-06-11 | Traditional | PDF ↗ |
| K143572 | Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK | Osteomed Implantes, Ltda | 2015-06-10 | Traditional | PDF ↗ |
| K142269 | Reliance Cervical IBF System | Reliance Medical Systems, LLC | 2015-06-09 | Traditional | PDF ↗ |
| K142586 | Captiva Spine FuselOX Cervical IBF System | Captiva Spine | 2015-05-28 | Traditional | PDF ↗ |
| K150130 | Ascendant TM Cervical Spacer System | Exactech, Inc. | 2015-05-28 | Traditional | PDF ↗ |
| K150521 | Interbody Fusion (IBF)/Vertebral Body Replacement(VBR) System | Rti Surgical, Inc. Dba Rti Biologics | 2015-05-15 | Traditional | PDF ↗ |
| K142744 | Mecta-C TiPEEK | Medacta International | 2015-05-07 | Traditional | PDF ↗ |
| K142456 | GPS Spacers | G Surgical, LLC | 2015-04-10 | Traditional | PDF ↗ |
| K143360 | LnK Cervical Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2015-04-03 | Special | PDF ↗ |
| K142218 | Coalition AGX Plate and Coalition AGX Spacer | Globus Medical, Inc. | 2015-03-31 | Traditional | PDF ↗ |
| K142345 | Talos-C(HA) Cervical Intervertebral Body Fusion Devices | Meditech Spine, LLC | 2015-02-22 | Traditional | PDF ↗ |
| K142152 | CONSTRUX MINI PEEK; SPACER SYSTEM, TI SPACER SYSTEM, CERVICAL STAND ALONE SYSTEM | Orthofix, Inc. | 2015-01-08 | Traditional | PDF ↗ |
| K142328 | nvc | Nvision Biomedical Technologies, LLC | 2014-12-23 | Traditional | PDF ↗ |
| K142041 | POROSTEON PHUSION METAL CERVICAL CAGE | Porosteon, Inc. | 2014-12-19 | Traditional | PDF ↗ |
| K142264 | Valeo C Spacer System, Valeo II C IBF Device | Amedica Corp. | 2014-12-08 | Traditional | PDF ↗ |
| K141333 | ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE | Spinefrontier, Inc. | 2014-11-25 | Traditional | PDF ↗ |
| K142251 | AVS AS PEEK Spacer | Stryker Corporation | 2014-11-19 | Traditional | PDF ↗ |
| K142050 | NUVASIVE COROENT SMALL CONTOURED INTERBODY SYSTEM | Nu Vasive, Incorporated | 2014-10-29 | Traditional | PDF ↗ |
| K142026 | SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE | Spinefrontier, Inc. | 2014-10-20 | Traditional | PDF ↗ |
| K142450 | DIVERGENCE Anterior Cervical Fusion System | Medtronic Sofamor Danek USA, Inc. | 2014-10-01 | Special | PDF ↗ |
| K141337 | ARENA-C | Spinefrontier, Inc. | 2014-09-08 | Traditional | PDF ↗ |
| K140280 | FORTICORE | Nanovis, LLC | 2014-09-05 | Traditional | PDF ↗ |
| K140786 | XENCO MEDICAL CERVICAL INTERBODY SYSTEM | Xenco Medical, LLC | 2014-09-03 | Traditional | PDF ↗ |
| K141129 | EXACTECH CERVICAL SPACER SYSTEM | Exactech, Inc. | 2014-08-15 | Traditional | PDF ↗ |
| K140921 | COROENT SMALL INTERBODY SYSTEM | Nu Vasive, Incorporated | 2014-07-28 | Traditional | PDF ↗ |
| K140864 | VELOXTM INTERBODY FUSION SYSTEM | U&I Corp. | 2014-07-22 | Traditional | PDF ↗ |
| K132732 | MEDYSSEY ANTERIOR CERVICAL FUSION CAGE | Medyssey USA, Inc. | 2014-07-18 | Traditional | PDF ↗ |
| K133784 | VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION | Zimmer Trabecular Metal Technology | 2014-07-07 | Traditional | PDF ↗ |
| K140066 | INFILL CERVICAL | Pinnacle Spine Group, LLC | 2014-05-05 | Traditional | PDF ↗ |
| K133653 | ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2014-04-28 | Traditional | PDF ↗ |
| K133815 | INTESS CERVICAL CAGE SYSTEM | Kalitec Direct, LLC | 2014-04-16 | Traditional | PDF ↗ |
| K140003 | COROENT SMALL INTERBODY SYSTEM | Nuvasive, Inc. | 2014-04-03 | Traditional | PDF ↗ |
| K132483 | INNESIS PEEK CERVICAL CAGE | Bk Meditech, Co., Ltd. | 2014-04-02 | Traditional | PDF ↗ |
| K133529 | CAMBER SPINE COVERIS CERVICAL CAGE | Camber Spine | 2014-03-20 | Traditional | PDF ↗ |
| K132926 | VELOFIXTM INTERBODY FUSION SYSTEM | U&I Corp. | 2014-03-05 | Traditional | PDF ↗ |
| K132991 | C-BOX PEEK CERVICAL IBF | Innovasis, Inc. | 2014-02-12 | Traditional | PDF ↗ |
| K133623 | C-PLUS | Pioneer Surgical Technology, Inc. | 2014-02-10 | Traditional | PDF ↗ |
| K133321 | ALAMO C | Alliance Partners, LLC | 2014-01-09 | Special | PDF ↗ |
| K130317 | GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM | Genesys Spine | 2013-12-11 | Traditional | PDF ↗ |
| K132584 | PERIMETER C SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2013-12-04 | Traditional | PDF ↗ |
| K132718 | INTEGRITY SPINE CORE SYSTEM | Integrity Spine | 2013-11-18 | Traditional | PDF ↗ |
| K130853 | IDYS(TM) C | Clariance | 2013-11-13 | Traditional | PDF ↗ |
| K130573 | TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF | Tyber Medical, LLC | 2013-09-30 | Traditional | PDF ↗ |
| K130177 | ANATOMIC PEEK CERVICAL FUSION SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2013-09-23 | Traditional | PDF ↗ |
| K131429 | RELIANCE CERVICAL IBF SYSTEM | Reliance Medical Systems, LLC | 2013-09-23 | Traditional | PDF ↗ |
| K130948 | C-FUSE CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM | Southern Spine, LLC | 2013-08-14 | Traditional | PDF ↗ |
| K121178 | TRANSCORP ACIF SYSTEM | Transcorp, Inc. | 2013-07-05 | Special | PDF ↗ |
| K122588 | VUSION CS PLUS | Ortho Development Corp. | 2013-06-12 | Traditional | PDF ↗ |
| K122801 | PROVIDENCE CERVICAL CAGE | Providence Medical Technology, Inc. | 2013-05-24 | Traditional | PDF ↗ |
| K123909 | AESCULAP CESPACE XP | Aesculap Implant System, Inc. | 2013-04-15 | Traditional | PDF ↗ |
| K122850 | TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES | Meditech Advisors, LLC | 2013-03-28 | Traditional | PDF ↗ |
| K122872 | INTERVERTEBRAL BODY FUSION DEVICE | Dio Medical Co., Ltd. | 2013-02-28 | Traditional | PDF ↗ |
| K122518 | SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGE | Bm Korea Co., Ltd. | 2013-02-15 | Special | PDF ↗ |
| K123206 | MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEM | Maxim Surgical | 2013-02-07 | Traditional | PDF ↗ |
| K120603 | VARILIFT -C | Wenzel Spine | 2013-01-29 | Traditional | PDF ↗ |
| K123388 | K7C SPACER | K7, LLC | 2013-01-04 | Traditional | PDF ↗ |
| K121649 | CONSTRUX MINI PEEK TI SPACER SYSTEM | Orthofix | 2012-11-29 | Traditional | PDF ↗ |
| K121741 | 4-WEB CERVICAL STS (SPINAL TRUSS SYSTEM) | 4-Web, Inc. | 2012-10-18 | Traditional | PDF ↗ |
| K122085 | STINGRAY CERVICAL CAGE | Omni Surgical, LP Dba Spine360 | 2012-10-17 | Abbreviated | PDF ↗ |
| K122366 | TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE | Spineart | 2012-10-04 | Special | PDF ↗ |
| K122444 | CERVICAL CAGE | Eisertech, LLC | 2012-08-30 | Special | PDF ↗ |
| K120486 | AVS AS PEEK SPACER | Stryker Spine | 2012-08-20 | Traditional | PDF ↗ |
| K121320 | C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE | Medyssey Co, Ltd. | 2012-08-10 | Traditional | PDF ↗ |
| K121569 | MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM | Accel Spine | 2012-07-27 | Traditional | PDF ↗ |
| K120345 | HONOUR SPACER SYSTEM | Nexxt Spine, LLC | 2012-06-13 | Traditional | PDF ↗ |
| K120275 | SYNTHES ACIS/VERTEBRAL SPACER CR | Synthes (Usa), LLC | 2012-05-25 | Traditional | PDF ↗ |
| K120840 | LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM | L&K BIOMED Co., Ltd. | 2012-05-24 | Traditional | PDF ↗ |
| K120396 | RELIANCE CERVICAL IBF SYSTEM | Reliance Medical Systems, LLC | 2012-05-08 | Traditional | PDF ↗ |
| K112801 | AYERS ROCK CERVICAL CAGE | Qualgenix | 2012-05-01 | Traditional | PDF ↗ |
| K120517 | DEPUY PULSE CERVICAL CAGE SYSTEM | Medos International SARL | 2012-04-26 | Traditional | PDF ↗ |
| K111820 | SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLIF CAGE | Bm Korea Co., Ltd. | 2012-03-14 | Traditional | PDF ↗ |
| K113518 | ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM | Spinefrontier, Inc. | 2012-02-16 | Abbreviated | PDF ↗ |
| K120143 | ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL | Apollo Spine | 2012-02-16 | Special | PDF ↗ |
Product code ODP · Class II · Orthopedic. Data: openFDA.