Atlas FDA

KWP

430 FDA 510(k) clearances · Product code

88 daysmedian time to decision
288 days90th percentile
430clearances measured

FDA profile

Official device name
Appliance, Fixation, Spinal Interlaminal
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3050
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 525 · 2022: 335 · 2023: 332 · 2024: 436 · 2025: 501 · 2026: 416
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
LnK Posterior Cervical Fixation System (K143278)L&K BIOMED Co., Ltd.2015-07-29
OASYS System (K150753)Stryker Corporation2015-06-09
Sure Lok Mini Posterior Cervical/Upper Thoracic System (K150851)Precision Spine, Inc.2015-06-04
Reliance Posterior Cervical-Thoracic System (K142867)Reliance Medical Systems, LLC2015-04-29
Streamline OCT Occipito-Cervico-Thoracic System (K150254)Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2015-04-28
SOLSTICE OCT System (K142253)Life Spine, Inc.2015-04-23
SOLSTICE OCT System (K150229)Life Spine, Inc.2015-04-07
SOLSTICE OCT System (K143249)Life Spine, Inc.2015-04-07
OASYS System (K142741)Stryker Corporation2015-01-15
Caspian OCT/MESA Mini/DENALI Mini Spinal System (K142558)K2m2014-12-22
NEXTGEN ALTIUS OCT SYSTEM (K140734)Ebi, LLC2014-12-15
EXPEDIUM Spine System/Synapse System (K142460)Johnson and Johnson2014-10-01
SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM (K141897)Synthes USA Products, LLC2014-09-25
CASPIAN SPINAL SYSTEM (K141284)K2m, Inc.2014-07-23
CASPIAN OCT SPINAL SYSTEM (K133288)K2m, Inc.2014-07-01
VIRAGE OCT SPINAL FIXATION SYSTEM (K133556)Zimmer Spine, Inc.2014-06-02
GIBRALT ROD-TO-ROD CROSS CONNECTORS (K140645)Exactech Sarasota2014-04-11
STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM (K133374)Pioneer Surgical Technology, Inc. (Rti Surgical, I2014-03-19
BLACKBIRD SPINAL SYSTEM (K133214)Choicespine, LP2014-03-07
CENTURION POCT SYSTEM (K131833)Orthofix, Inc.2014-01-30
KESTREL POSTERIOR CERVICAL SPINE SYSTEM (K132122)Omni Surgical, LLC Dba Spine3602014-01-22
SYNAPSE SYSTEM (K133698)Synthes USA Products, LLC2014-01-16
CERTEX OCT SPINAL IMPLANT SYSTEM (K133094)X-Spine Systems, Inc.2013-12-11
TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM (K132504)Corelink, LLC2013-11-25
MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEM (K132900)Intelligent Implant Systems, LLC2013-10-25
LOTUS (K131427)Spinal Elements, Inc.2013-10-24
MOUNTAINEER OCT SPINAL SYSTEM (K132332)Medos International SARL2013-08-22
LANX SPINAL FIXATION SYSTEM (K131156)Lanx, Inc.2013-05-24
VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM (K123906)Medtronic Sofamor Danek USA, Inc.2013-04-01
PASS OCT SPINAL SYSTEM (K121979)Medicrea International2013-03-21
ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS (K123783)Globus Medical, Inc.2013-03-14
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM (K123656)Medtronic Sofamor Danek USA, Inc.2013-02-25
GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES (K121877)Exactech, Inc.2013-02-12
SPINEOLOGY SPINOUS PROCESS PLATE (K123232)Spineology, Inc.2013-02-07
STABILINK MIS SPINAL FIXATION SYSTEM (K123093)Southern Spine, LLC2012-12-20
VERTEX RECONSTRUCTION SYSTEM (K123568)Medtronic Sofamor Danek USA, Inc.2012-12-18
VERTIFLEX SPINOUS PROCESS FIXATION PLATE (K122509)Vertiflex, Inc.2012-12-17
PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM (K121725)Pioneer Surgical Technology, Inc.2012-11-07
RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM (K122292)Reliance Medical Systems, LLC2012-10-24
SOLSTICE CROSS CONNECTOR (K120998)Life Spine2012-10-01
NEXTGEN ALTIUS OCT SYSTEM (K122378)Biomet Spine (Aka Ebi, LLC)2012-09-20
RENOIR POSTERIOR CERVIAL FIXATION SYSTEM (K121136)Accel Spine2012-08-09
CASIAN, 3.5/4.5 CONNECTORS (K121808)K2m, Inc.2012-07-20
M.U.S.T PEDICLE SCREW SYSTEM (K121115)Medacta International2012-07-18
VERTEX RCCONSTRUCTION SYSTEM (K121191)Medtronic Sofamor Danek, Inc.2012-06-29
NEXTGEN ALTIUS OCT SYSTEM (K113593)Biomet Spine (Aka Ebi, LLC)2012-04-17
REXIOUS HOOK FIXATION SYSTEMS (K113324)Dio Medical Co., Ltd.2012-03-28
PIONEER POSTERIOR CERVICO THORACIC SYSTEM (K112757)Pioneer Surgical Technology, Inc.2012-03-12
NEON SYSTEM (K113346)Ulrich GmbH & Co. KG2012-02-28
COFLEX-F (K112595)Paradigm Spine, LLC2012-02-13
OASYS SPINAL SYSTEM (K111719)Stryker Spine2012-01-19
CASPIAN (K113654)K2m, Inc.2012-01-12
AXLE PEEK INTERSPINOUS FUSION SYSTEM (K112592)X-Spine Systems, Inc.2011-12-05
SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM (K112025)Spinal USA2011-09-15
BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM (K103205)Alphatec Spine, Inc.2011-06-02
ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME RODS) (K111183)Orthofix, Inc.2011-05-24
ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM (K110963)Globus Medical, Inc.2011-05-05
LANX SPINAL FIXATION SYSTEM (K103091)Lanx, Inc.2011-04-15
MOUNTAINEER OCT SPINAL SYSTEM (K110353)Depuy Spine, Inc.2011-04-07
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM (K110522)Medtronic Sofamor Danek USA, Inc.2011-04-01
PIONEER SPINAL PROCESS FUSION PLATE (K110367)Pioneer Surgical Technology, Inc.2011-03-23
CD HORIZON SPINAL SYSTEM (K102886)Medtronic Sofamor Danek, Inc.2011-01-26
SP-FIX SPINOUS PROCESS FIXATION PLATE (K102195)Globus Medical, Inc.2011-01-19
CASPIAN SPINAL SYSTEM (K103232)K2m, Inc.2011-01-13
AXLE INTERSPINOUS FUSION SYSTEM (K101471)X-Spine Systems, Inc.2010-11-24
MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (K100888)Lanx, Inc.2010-11-15
MODIFICATION TO: OASYS SYSTEM (K101183)Stryker Spine2010-11-09
RELIANCE SPINAL SCREW SYSTEM (K101112)Reliance Medical Systems2010-11-04
PIONEER SPINOUS PROCESS FUSION PLATE (K101525)Pioneer Surgical Technology2010-10-22
PARADIGM INTERSPINOUS FUSION PLATE (K093438)Paradigm Spine, LLC2010-10-06
CASPIAN SPINAL SYSTEM (K101084)K2m, Inc.2010-10-04
VEGA SPAN SPINOUS PROCESS PLATE SYSTEM (K102020)Spinefrontier, Inc.2010-09-01
PRIMAL OK INTERSPINOUS FUSION SYSTEM (K100354)Osteomed LP2010-08-17
NUVASIVE VUEPOINT OCT SYSTEM (K093319)Nuvasive, Inc.2010-06-23
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM (K100685)Alphatec Spine, Inc.2010-06-18
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) (K100191)Lanx, Inc.2010-04-15
APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHER (K092825)Spinecraft, Inc.2010-03-16
PIONEER POSTERIOR CERVICO-THORACIC SYSTEM (K092295)Pioneer Surgical Technology2010-02-19
MODIFICATION TO CASPIAN SPINAL SYSTEM (K093534)K2m, Inc.2009-12-16
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (K092656)Lanx, Inc.2009-11-24
GSO PCT SPINAL SYSTEM (K091359)Gold Standard Orthopaedics, LLC2009-09-02
SENTINEL SPINAL SYSTEM (K090343)Life Spine2009-08-11
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM (K091365)Medtronic Soafamor Danek2009-08-06
SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM (K091689)Synthes (Usa)2009-07-10
ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM (K090565)Globus Medical, Inc.2009-06-30
NEXLINK OCT SYSTEM, MODEL 7000 SERIES (K090060)Abbott Spine, Inc.2009-06-02
SYNTHES SYNAPSE TRANSCONNECTOR (K090549)Synthes Spine2009-05-21
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM (K090714)Medtronic Sofamor Danek2009-04-17
MODIFICATION TO: LANX SPINAL FIXATION SYSTEM (K090252)Lanx, Inc.2009-03-04
VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM (K082728)Medtronic Sofamor Danek USA, Inc.2009-01-16
MESA AND RANGE SPINAL SYSTEMS (K082769)K2m, Inc.2008-12-11
PROTEX CT CERVICOTHORACIC SPINAL SYSTEM (K081906)Globus Medical, Inc.2008-11-14
VERTEX RECONSTRUCTION SYSTEM (K083071)Medtronic Sofamor Danek2008-11-14
CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS (K081107)K2m, Inc.2008-10-10
VERTEX RECONSTRUCTION SYSTEM (K081297)Medtronic Sofamor Danek2008-06-11
MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM (K080790)Theken Spine, LLC2008-04-29
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM (K080805)Medtronic Sofamor Danek2008-04-18
SIERRA (K072729)Seaspine, Inc.2008-04-17
SIERRA SYSTEM (K080526)Seaspine, Inc.2008-04-16
SPINOUS PROCESS PLATE SYSTEM (K073278)Nuvasive, Inc.2008-03-28
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Every clearance here is in the API, with alerts when new ones post.