FDA Product Code
FDA Product Code KWP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3050
510(k) Clearances — 430 records · page 1 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K143278 | LnK Posterior Cervical Fixation System | L&K BIOMED Co., Ltd. | 2015-07-29 | Traditional | PDF ↗ |
| K150753 | OASYS System | Stryker Corporation | 2015-06-09 | Traditional | PDF ↗ |
| K150851 | Sure Lok Mini Posterior Cervical/Upper Thoracic System | Precision Spine, Inc. | 2015-06-04 | Special | PDF ↗ |
| K142867 | Reliance Posterior Cervical-Thoracic System | Reliance Medical Systems, LLC | 2015-04-29 | Special | PDF ↗ |
| K150254 | Streamline OCT Occipito-Cervico-Thoracic System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 2015-04-28 | Traditional | PDF ↗ |
| K142253 | SOLSTICE OCT System | Life Spine, Inc. | 2015-04-23 | Traditional | PDF ↗ |
| K143249 | SOLSTICE OCT System | Life Spine, Inc. | 2015-04-07 | Traditional | PDF ↗ |
| K150229 | SOLSTICE OCT System | Life Spine, Inc. | 2015-04-07 | Traditional | PDF ↗ |
| K142741 | OASYS System | Stryker Corporation | 2015-01-15 | Traditional | PDF ↗ |
| K142558 | Caspian OCT/MESA Mini/DENALI Mini Spinal System | K2m | 2014-12-22 | Special | PDF ↗ |
| K140734 | NEXTGEN ALTIUS OCT SYSTEM | Ebi, LLC | 2014-12-15 | Traditional | PDF ↗ |
| K142460 | EXPEDIUM Spine System/Synapse System | Johnson and Johnson | 2014-10-01 | Special | PDF ↗ |
| K141897 | SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM | Synthes USA Products, LLC | 2014-09-25 | Traditional | PDF ↗ |
| K141284 | CASPIAN SPINAL SYSTEM | K2m, Inc. | 2014-07-23 | Special | PDF ↗ |
| K133288 | CASPIAN OCT SPINAL SYSTEM | K2m, Inc. | 2014-07-01 | Traditional | PDF ↗ |
| K133556 | VIRAGE OCT SPINAL FIXATION SYSTEM | Zimmer Spine, Inc. | 2014-06-02 | Traditional | PDF ↗ |
| K140645 | GIBRALT ROD-TO-ROD CROSS CONNECTORS | Exactech Sarasota | 2014-04-11 | Special | PDF ↗ |
| K133374 | STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM | Pioneer Surgical Technology, Inc. (Rti Surgical, I | 2014-03-19 | Traditional | PDF ↗ |
| K133214 | BLACKBIRD SPINAL SYSTEM | Choicespine, LP | 2014-03-07 | Traditional | PDF ↗ |
| K131833 | CENTURION POCT SYSTEM | Orthofix, Inc. | 2014-01-30 | Traditional | PDF ↗ |
| K132122 | KESTREL POSTERIOR CERVICAL SPINE SYSTEM | Omni Surgical, LLC Dba Spine360 | 2014-01-22 | Traditional | PDF ↗ |
| K133698 | SYNAPSE SYSTEM | Synthes USA Products, LLC | 2014-01-16 | Special | PDF ↗ |
| K133094 | CERTEX OCT SPINAL IMPLANT SYSTEM | X-Spine Systems, Inc. | 2013-12-11 | Traditional | PDF ↗ |
| K132504 | TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM | Corelink, LLC | 2013-11-25 | Traditional | PDF ↗ |
| K132900 | MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM | Intelligent Implant Systems, LLC | 2013-10-25 | Traditional | PDF ↗ |
| K131427 | LOTUS | Spinal Elements, Inc. | 2013-10-24 | Traditional | PDF ↗ |
| K132332 | MOUNTAINEER OCT SPINAL SYSTEM | Medos International SARL | 2013-08-22 | Special | PDF ↗ |
| K131156 | LANX SPINAL FIXATION SYSTEM | Lanx, Inc. | 2013-05-24 | Special | PDF ↗ |
| K123906 | VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2013-04-01 | Traditional | PDF ↗ |
| K121979 | PASS OCT SPINAL SYSTEM | Medicrea International | 2013-03-21 | Traditional | PDF ↗ |
| K123783 | ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS | Globus Medical, Inc. | 2013-03-14 | Traditional | PDF ↗ |
| K123656 | VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2013-02-25 | Traditional | PDF ↗ |
| K121877 | GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES | Exactech, Inc. | 2013-02-12 | Traditional | PDF ↗ |
| K123232 | SPINEOLOGY SPINOUS PROCESS PLATE | Spineology, Inc. | 2013-02-07 | Traditional | PDF ↗ |
| K123093 | STABILINK MIS SPINAL FIXATION SYSTEM | Southern Spine, LLC | 2012-12-20 | Traditional | PDF ↗ |
| K123568 | VERTEX RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2012-12-18 | Special | PDF ↗ |
| K122509 | VERTIFLEX SPINOUS PROCESS FIXATION PLATE | Vertiflex, Inc. | 2012-12-17 | Traditional | PDF ↗ |
| K121725 | PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM | Pioneer Surgical Technology, Inc. | 2012-11-07 | Traditional | PDF ↗ |
| K122292 | RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM | Reliance Medical Systems, LLC | 2012-10-24 | Traditional | PDF ↗ |
| K120998 | SOLSTICE CROSS CONNECTOR | Life Spine | 2012-10-01 | Special | PDF ↗ |
| K122378 | NEXTGEN ALTIUS OCT SYSTEM | Biomet Spine (Aka Ebi, LLC) | 2012-09-20 | Special | PDF ↗ |
| K121136 | RENOIR POSTERIOR CERVIAL FIXATION SYSTEM | Accel Spine | 2012-08-09 | Traditional | PDF ↗ |
| K121808 | CASIAN, 3.5/4.5 CONNECTORS | K2m, Inc. | 2012-07-20 | Special | PDF ↗ |
| K121115 | M.U.S.T PEDICLE SCREW SYSTEM | Medacta International | 2012-07-18 | Traditional | PDF ↗ |
| K121191 | VERTEX RCCONSTRUCTION SYSTEM | Medtronic Sofamor Danek, Inc. | 2012-06-29 | Traditional | PDF ↗ |
| K113593 | NEXTGEN ALTIUS OCT SYSTEM | Biomet Spine (Aka Ebi, LLC) | 2012-04-17 | Traditional | PDF ↗ |
| K113324 | REXIOUS HOOK FIXATION SYSTEMS | Dio Medical Co., Ltd. | 2012-03-28 | Traditional | PDF ↗ |
| K112757 | PIONEER POSTERIOR CERVICO THORACIC SYSTEM | Pioneer Surgical Technology, Inc. | 2012-03-12 | Special | PDF ↗ |
| K113346 | NEON SYSTEM | Ulrich GmbH & Co. KG | 2012-02-28 | Traditional | PDF ↗ |
| K112595 | COFLEX-F | Paradigm Spine, LLC | 2012-02-13 | Traditional | PDF ↗ |
| K111719 | OASYS SPINAL SYSTEM | Stryker Spine | 2012-01-19 | Special | PDF ↗ |
| K113654 | CASPIAN | K2m, Inc. | 2012-01-12 | Special | PDF ↗ |
| K112592 | AXLE PEEK INTERSPINOUS FUSION SYSTEM | X-Spine Systems, Inc. | 2011-12-05 | Special | PDF ↗ |
| K112025 | SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM | Spinal USA | 2011-09-15 | Traditional | PDF ↗ |
| K103205 | BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM | Alphatec Spine, Inc. | 2011-06-02 | Traditional | PDF ↗ |
| K111183 | ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME RODS) | Orthofix, Inc. | 2011-05-24 | Special | PDF ↗ |
| K110963 | ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM | Globus Medical, Inc. | 2011-05-05 | Special | PDF ↗ |
| K103091 | LANX SPINAL FIXATION SYSTEM | Lanx, Inc. | 2011-04-15 | Special | PDF ↗ |
| K110353 | MOUNTAINEER OCT SPINAL SYSTEM | Depuy Spine, Inc. | 2011-04-07 | Special | PDF ↗ |
| K110522 | VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2011-04-01 | Special | PDF ↗ |
| K110367 | PIONEER SPINAL PROCESS FUSION PLATE | Pioneer Surgical Technology, Inc. | 2011-03-23 | Special | PDF ↗ |
| K102886 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | 2011-01-26 | Traditional | PDF ↗ |
| K102195 | SP-FIX SPINOUS PROCESS FIXATION PLATE | Globus Medical, Inc. | 2011-01-19 | Traditional | PDF ↗ |
| K103232 | CASPIAN SPINAL SYSTEM | K2m, Inc. | 2011-01-13 | Special | PDF ↗ |
| K101471 | AXLE INTERSPINOUS FUSION SYSTEM | X-Spine Systems, Inc. | 2010-11-24 | Traditional | PDF ↗ |
| K100888 | MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM | Lanx, Inc. | 2010-11-15 | Special | PDF ↗ |
| K101183 | MODIFICATION TO: OASYS SYSTEM | Stryker Spine | 2010-11-09 | Special | PDF ↗ |
| K101112 | RELIANCE SPINAL SCREW SYSTEM | Reliance Medical Systems | 2010-11-04 | Special | PDF ↗ |
| K101525 | PIONEER SPINOUS PROCESS FUSION PLATE | Pioneer Surgical Technology | 2010-10-22 | Traditional | PDF ↗ |
| K093438 | PARADIGM INTERSPINOUS FUSION PLATE | Paradigm Spine, LLC | 2010-10-06 | Traditional | PDF ↗ |
| K101084 | CASPIAN SPINAL SYSTEM | K2m, Inc. | 2010-10-04 | Traditional | PDF ↗ |
| K102020 | VEGA SPAN SPINOUS PROCESS PLATE SYSTEM | Spinefrontier, Inc. | 2010-09-01 | Traditional | PDF ↗ |
| K100354 | PRIMAL OK INTERSPINOUS FUSION SYSTEM | Osteomed LP | 2010-08-17 | Traditional | PDF ↗ |
| K093319 | NUVASIVE VUEPOINT OCT SYSTEM | Nuvasive, Inc. | 2010-06-23 | Special | PDF ↗ |
| K100685 | ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM | Alphatec Spine, Inc. | 2010-06-18 | Special | PDF ↗ |
| K100191 | LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) | Lanx, Inc. | 2010-04-15 | Special | PDF ↗ |
| K092825 | APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHER | Spinecraft, Inc. | 2010-03-16 | Special | PDF ↗ |
| K092295 | PIONEER POSTERIOR CERVICO-THORACIC SYSTEM | Pioneer Surgical Technology | 2010-02-19 | Traditional | PDF ↗ |
| K093534 | MODIFICATION TO CASPIAN SPINAL SYSTEM | K2m, Inc. | 2009-12-16 | Special | PDF ↗ |
| K092656 | LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM | Lanx, Inc. | 2009-11-24 | Traditional | PDF ↗ |
| K091359 | GSO PCT SPINAL SYSTEM | Gold Standard Orthopaedics, LLC | 2009-09-02 | Traditional | PDF ↗ |
| K090343 | SENTINEL SPINAL SYSTEM | Life Spine | 2009-08-11 | Traditional | PDF ↗ |
| K091365 | VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM | Medtronic Soafamor Danek | 2009-08-06 | Traditional | PDF ↗ |
| K091689 | SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM | Synthes (Usa) | 2009-07-10 | Special | PDF ↗ |
| K090565 | ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM | Globus Medical, Inc. | 2009-06-30 | Special | PDF ↗ |
| K090060 | NEXLINK OCT SYSTEM, MODEL 7000 SERIES | Abbott Spine, Inc. | 2009-06-02 | Traditional | PDF ↗ |
| K090549 | SYNTHES SYNAPSE TRANSCONNECTOR | Synthes Spine | 2009-05-21 | Special | PDF ↗ |
| K090714 | VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek | 2009-04-17 | Special | PDF ↗ |
| K090252 | MODIFICATION TO: LANX SPINAL FIXATION SYSTEM | Lanx, Inc. | 2009-03-04 | Special | PDF ↗ |
| K082728 | VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2009-01-16 | Traditional | PDF ↗ |
| K082769 | MESA AND RANGE SPINAL SYSTEMS | K2m, Inc. | 2008-12-11 | Special | PDF ↗ |
| K083071 | VERTEX RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek | 2008-11-14 | Special | PDF ↗ |
| K081906 | PROTEX CT CERVICOTHORACIC SPINAL SYSTEM | Globus Medical, Inc. | 2008-11-14 | Special | PDF ↗ |
| K081107 | CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS | K2m, Inc. | 2008-10-10 | Traditional | PDF ↗ |
| K081297 | VERTEX RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek | 2008-06-11 | Special | PDF ↗ |
| K080790 | MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM | Theken Spine, LLC | 2008-04-29 | Special | PDF ↗ |
| K080805 | MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM | Medtronic Sofamor Danek | 2008-04-18 | Special | PDF ↗ |
| K072729 | SIERRA | Seaspine, Inc. | 2008-04-17 | Special | PDF ↗ |
| K080526 | SIERRA SYSTEM | Seaspine, Inc. | 2008-04-16 | Special | PDF ↗ |
| K073278 | SPINOUS PROCESS PLATE SYSTEM | Nuvasive, Inc. | 2008-03-28 | Traditional | PDF ↗ |
Product code KWP · Class II · Orthopedic. Data: openFDA.