FDA Product Code
FDA Product Code OVD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3080
510(k) Clearances — 205 records · page 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K173606 | SeaSpine Vu aPOD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu aPOD Prime Intervertebral Body Fusion Device | SeaSpine Orthopedics Corporation | 2018-04-13 | Traditional | PDF ↗ |
| K173082 | Arco-SA Lumbar Cage System | Neurostructures, Inc. | 2018-03-29 | Traditional | PDF ↗ |
| K172941 | CASCADIA Interbody System | K2m | 2018-02-12 | Traditional | PDF ↗ |
| K172019 | Brisbane ALIF Device, Gladstone ALIF Device | Signature Orthopaedics Pty, Ltd. | 2017-11-29 | Traditional | PDF ↗ |
| K172083 | Idys ALIF System | Clariance, Sas | 2017-11-08 | Traditional | PDF ↗ |
| K172328 | SOVEREIGN Spinal System | Medtronic Sofamor Danek USA, Inc. | 2017-11-02 | Traditional | PDF ↗ |
| K170157 | INDEPENDENCE® Spacers | Globus Medical, Inc. | 2017-09-25 | Traditional | PDF ↗ |
| K170855 | T-Rex Standalone ALIF | Siats, LLC | 2017-09-07 | Traditional | PDF ↗ |
| K171567 | IRIX-A Lumbar Integrated Fusion System | X-Spine Systems, Inc. | 2017-08-28 | Traditional | PDF ↗ |
| K163670 | Rampart One Lumbar Interbody Fusion Device | Spineology, Inc. | 2017-05-08 | Traditional | PDF ↗ |
| K170592 | NuVasive BASE Interfixated Titanium System | Nu Vasive, Incorporated | 2017-04-26 | Traditional | PDF ↗ |
| K162236 | Ax Stand-Alone ALIF System | Innovasis, Inc. | 2017-04-20 | Traditional | PDF ↗ |
| K163269 | Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device | Titan Spine, LLC | 2017-04-13 | Traditional | PDF ↗ |
| K170455 | MectaLIF Anterior Stand Alone | Medacta International S.A. | 2017-03-16 | Special | PDF ↗ |
| K163543 | Biomet Fusion System | Zimmer Biomet Spine, Inc. | 2017-02-28 | Special | PDF ↗ |
| K162680 | SOVEREIGN® Spinal System | Medtronic Sofamor Danek USA, Inc. | 2016-12-14 | Traditional | PDF ↗ |
| K162351 | SeaSpine® Vu aPOD Prime NanoMetalene® Intervertebral Body Fusion Device | SeaSpine Orthopedics Corporation | 2016-12-01 | Traditional | PDF ↗ |
| K161993 | Leva® Anterior Interbody System | Spine Wave, Inc. | 2016-11-22 | Traditional | PDF ↗ |
| K161379 | ELSA Spacers | Globus Medical, Inc. | 2016-09-29 | Traditional | PDF ↗ |
| K161173 | Avenue® T TLIF Cage | Ldr Spine USA, Inc. | 2016-09-28 | Traditional | PDF ↗ |
| K161129 | PILLAR SA PTC | Orthofix, Inc. | 2016-09-08 | Traditional | PDF ↗ |
| K160597 | INDEPENDENCE MIS Spacers | Globus Medical, Inc. | 2016-08-29 | Traditional | PDF ↗ |
| K160605 | MectaLIF Anterior Stand-Alone | Medacta International | 2016-07-21 | Traditional | PDF ↗ |
| K161223 | TransContinental® M Spacers and InterContinental® Plate-Spacers | Globus Medical, Inc. | 2016-07-15 | Traditional | PDF ↗ |
| K153720 | ENZA Zero-Profile Anterior Interbody Fusion | Camber Spine Technologies | 2016-05-03 | Traditional | PDF ↗ |
| K160051 | NuVasive® Interfixated Interbody System | Nu Vasive, Incorporated | 2016-04-20 | Traditional | PDF ↗ |
| K160291 | Optimus ALIF System | Amendia, Inc. | 2016-02-18 | Special | PDF ↗ |
| K151312 | VerteLP Interbody Fusion Device | Vgi, LLC | 2016-01-13 | Traditional | PDF ↗ |
| K151481 | Sahara Stabilization System | K2m, Inc. | 2015-12-21 | Traditional | PDF ↗ |
| K152943 | NuVasive Foundation-LL System | Nu Vasive, Incorporated | 2015-12-01 | Traditional | PDF ↗ |
| K150673 | SYNFIX Evolution Secured Spacer System | Synthes (USA) Products, LLC | 2015-08-21 | Traditional | PDF ↗ |
| K151214 | ALIF Interfixated System | Nu Vasive, Incorporated | 2015-06-25 | Traditional | PDF ↗ |
| K142645 | Avenue T TLIF Cage | Ldr Spine USA, Inc. | 2015-06-11 | Traditional | PDF ↗ |
| K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015-06-08 | Traditional | PDF ↗ |
| K142487 | Chesapeake Stabilization System | K2m, Inc. | 2015-05-07 | Traditional | PDF ↗ |
| K142498 | MAGNIFY and MAGNIFY-S Spacers | Globus Medical, Inc. | 2015-02-26 | Traditional | PDF ↗ |
| K143228 | Ancora LLC Interbody Fusion Device | Frontier Medical Devices, Inc. | 2015-02-26 | Traditional | PDF ↗ |
| K141798 | SYPHER SPACER SYSTEM | Biogennix, LLC | 2015-02-19 | Traditional | PDF ↗ |
| K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System | Stryker Corporation | 2015-01-26 | Traditional | PDF ↗ |
| K141187 | IMPIX ALIF S/A | Medicrea International SA | 2015-01-15 | Traditional | PDF ↗ |
| K142271 | Zavation Z-Link Lumbar | Zavation, LLC | 2014-12-19 | Traditional | PDF ↗ |
| K133827 | A-LINK Z | Osteo Vasive, LLC | 2014-11-17 | Traditional | PDF ↗ |
| K142066 | AERO-LL LUMBAR CAGE SYSTEM | Stryker Corporation | 2014-11-13 | Traditional | PDF ↗ |
| K141942 | MIDLINE II TI | Centinel Spine, Inc. | 2014-11-07 | Traditional | PDF ↗ |
| K142095 | RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM | Renovis Surgical Technologies, Inc. | 2014-10-15 | Special | PDF ↗ |
| K141791 | BIOMET FUSION SYSTEM | Biomet Spine | 2014-10-09 | Traditional | PDF ↗ |
| K133947 | IRIX-A LUMBAR INTEGRATED FUSION SYSTEM | X-Spine Systems, Inc. | 2014-07-29 | Traditional | PDF ↗ |
| K140479 | COROENT XL-F SYSTEM | Nu Vasive, Incorporated | 2014-07-28 | Traditional | PDF ↗ |
| K133494 | CHESAPEAKE SPINAL SYSTEM | K2m, Inc. | 2014-06-10 | Traditional | PDF ↗ |
| K133328 | AERO-AL LUMBAR CAGE SYSTEM | Stryker Corporation | 2014-05-30 | Traditional | PDF ↗ |
| K132596 | PROPOSED OPTIMUS | Custom Spine, Inc. | 2014-04-11 | Traditional | PDF ↗ |
| K140106 | S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM | Renovis Surgical Technologies, Inc. | 2014-03-27 | Special | PDF ↗ |
| K133286 | MIDLINE (TM) | Centinel Spine, Inc. | 2014-01-09 | Special | PDF ↗ |
| K131276 | LATERAL SYNFIX | Synthes (USA) Products, LLC | 2014-01-06 | Traditional | PDF ↗ |
| K132559 | MONUMENT SPACERS | Globus Medical, Inc. | 2013-12-30 | Traditional | PDF ↗ |
| K131723 | COROENT SINGLE TAB SYSTEM | Nuvasive, Inc. | 2013-09-20 | Traditional | PDF ↗ |
| K131122 | S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM | Renovis Surgical Technologies, LLC | 2013-09-18 | Abbreviated | PDF ↗ |
| K130641 | LOGIC STAND-ALONE INTERVERTEBRAL BODY FUSION DEVICE | Binder Biomedical, Inc. | 2013-09-13 | Traditional | PDF ↗ |
| K130461 | STALIF X | Centinel Spine, Inc. | 2013-08-28 | Traditional | PDF ↗ |
| K131547 | LANX FUSION SYSTEM | Lanx, Inc. | 2013-07-12 | Special | PDF ↗ |
| K124034 | MECTALIF ANTERIOR | Medacta International | 2013-05-17 | Traditional | PDF ↗ |
| K130445 | VAULT ALIF SYSTEM | Spinal USA | 2013-04-25 | Special | PDF ↗ |
| K123045 | BRIGADE STANDALONE SYSTEM | Nuvasive, Inc. | 2013-04-16 | Special | PDF ↗ |
| K123767 | LANX FUSION SYSTEM- SA | Lanx, Inc. | 2013-03-18 | Traditional | PDF ↗ |
| K123993 | SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM | Alphatec Spine, Inc. | 2013-03-05 | Traditional | PDF ↗ |
| K112700 | FRONTIER SADL INTERBODY FUSION DEVICE | Frontier Medical Devices, Inc. | 2012-11-01 | Traditional | PDF ↗ |
| K120869 | ANCHOR-L LUMBAR CAGE | Stryker Spine | 2012-10-25 | Traditional | PDF ↗ |
| K122168 | VISUALIF CHALLENGING ACCESS PLATE | Spine Smith Partners L.P. | 2012-10-11 | Special | PDF ↗ |
| K121982 | SOVEREIGN SPINAL SYSTEM | Medtronic Sofamor Danek | 2012-07-26 | Special | PDF ↗ |
| K113285 | LDR SPINE USA AVENUE L INTERBODY FUSION | Ldr Spine USA, Inc. | 2012-07-26 | Traditional | PDF ↗ |
| K121211 | VU APOD INTERVERTEBRAL BODY FUSION DEVICE | Theken Spine, LLC | 2012-06-27 | Special | PDF ↗ |
| K120101 | INDEPENDENCE SPACER | Globus Medical, Inc. | 2012-03-27 | Special | PDF ↗ |
| K120557 | SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35 | Biomet Spine & Bone Healing Technologies | 2012-03-19 | Special | PDF ↗ |
| K120031 | CHESAPEAKE SPINAL SYSTEM | K2m, Inc. | 2012-03-16 | Special | PDF ↗ |
| K112561 | NUVASIVE COROENT NO-PROFILE SYSTEM | Nuvasive, Inc. | 2012-03-13 | Special | PDF ↗ |
| K110063 | SOVEREIGN SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2011-10-04 | Traditional | PDF ↗ |
| K110327 | LDR SPINE ROI-A INTERBODY FUSION SYSTEM | Ldr Spine USA | 2011-09-30 | Special | PDF ↗ |
| K111626 | ENDOSKELETON(R) TAS | Titan Spine, LLC | 2011-09-09 | Traditional | PDF ↗ |
| K111122 | AESCULAP SIBD XP SPINAL SYSTEM | Aesculap Implant Systems, Inc. | 2011-08-04 | Traditional | PDF ↗ |
| K103382 | INTERCONTINENTAL PLATE-SPACER | Globus Medical, Inc. | 2011-05-20 | Traditional | PDF ↗ |
| K103369 | VAULT ALIF SYSTEM | Spinal USA | 2011-04-04 | Traditional | PDF ↗ |
| K102402 | SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM | Alphatec Spine, Inc. | 2011-03-30 | Traditional | PDF ↗ |
| K102738 | LANX FUSION SYSTEM | Lanx, LLC | 2011-02-10 | Traditional | PDF ↗ |
| K102121 | ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR | Apollo Spine, Inc. | 2011-01-12 | Traditional | PDF ↗ |
| K100516 | ANYPLUS PEEK CAGES | GS Medical Co., Ltd. | 2010-12-03 | Traditional | PDF ↗ |
| K102090 | SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM | Spine Smith Partners L.P. | 2010-09-30 | Special | PDF ↗ |
| K101310 | VU APOD INTERVERTEBRAL BODY FUSION DEVICE | Theken Spine, LLC | 2010-09-02 | Traditional | PDF ↗ |
| K100802 | AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM | Aesculap Implant Systems, Inc. | 2010-07-20 | Traditional | PDF ↗ |
| K100043 | COROENT XLR STANDALONE SYSTEM | Nuvasive, Inc. | 2010-06-16 | Traditional | PDF ↗ |
| K093808 | INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE | Incite Innovation, LLC | 2010-03-24 | Traditional | PDF ↗ |
| K093629 | SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM | Biomet Spine | 2010-03-09 | Traditional | PDF ↗ |
| K092211 | CHESAPEAKE SPINAL SYSTEM | K2m, Inc. | 2010-03-05 | Traditional | PDF ↗ |
| K091301 | LIFE SPINE STAND-ALONE SPACER SYSTEM | Life Spine | 2009-12-15 | Traditional | PDF ↗ |
| K091813 | INTREPID SPINAL SYSTEM | Medtronic Sofamor Danek | 2009-11-17 | Traditional | PDF ↗ |
| K083475 | LUCENT MAGNUM | Spinal Elements, Inc. | 2009-02-13 | Traditional | PDF ↗ |
| K082926 | ZUMA, MODEL 55-XXXX/56-XXXX | Seaspine, Inc. | 2008-12-22 | Traditional | PDF ↗ |
| K082252 | INDEPENDENCE SPACER | Globus Medical, Inc. | 2008-11-05 | Traditional | PDF ↗ |
| K081711 | LUCENT MAGNUM+ | Spinal Elements, Inc. | 2008-09-11 | Traditional | PDF ↗ |
| K081849 | BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE | Blackstone Medical, Inc. | 2008-08-28 | Special | PDF ↗ |
| K080822 | VU APOD INTERVERTABRAL BODY FUSION DEVICE | Theken Spine, LLC | 2008-07-02 | Traditional | PDF ↗ |
Product code OVD · Class II · Orthopedic. Data: openFDA.