Atlas FDA

MNH

309 FDA 510(k) clearances · Product code

90 daysmedian time to decision
247 days90th percentile
309clearances measured

FDA profile

Official device name
Orthosis, Spondylolisthesis Spinal Fixation
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3070
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 531 · 2022: 265 · 2023: 121 · 2024: 302 · 2025: 91 · 2026: 53
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
Reliance Spinal Screw System (K162066)Reliance Medical Systems, LLC2016-12-02
CastleLoc Spinal Fixation System (K162801)L&K BIOMED Co., Ltd.2016-11-03
FixxSure® X-Link (K162143)Innovasis, Inc.2016-09-23
Spinal fixation system (K161151)Canwell Medical Co., Ltd.2016-09-21
ANAX™ 5.5 Spinal System (K162189)U&I Corporation2016-08-30
HC Spinal System (K151362)Hung Chun Bio-S Co., Ltd.2016-05-05
Zavation Spinal System (K153404)Zavation, LLC2016-04-21
Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System (K160020)Captiva Spine2016-03-02
Spinal Inner Fixation System (K143013)Changzhou Dingjian Medical Appliance Co., Ltd.2015-12-11
Romeo posterior osteosynthesis system (K151695)Spineart2015-09-10
CapLOX II/TowerLOX Pedicle Screw System (K151116)Captiva Spine2015-06-26
Republic Spine Dark Star Spinal System (K150283)Republic Spine, LLC2015-04-29
PASS LP Spinal System (K142798)Medicrea International SA2015-03-25
ANAX 5.5 Spinal System (K143417)U&I Corporation2015-02-25
PedFuse Pedicle Screw System (K143377)Spinefrontier, Inc.2015-02-12
Ideal pedicle screw spinal system (K142957)Jiangsu Ideal Medical Science & Technology Co., Ltd.2015-01-30
CB PROT II Posterior Spinal System (K142655)Chin Bone Technique Corp2015-01-26
MAXIMIS SPINAL FIXATION SYSTEM (K140359)Valorem Surgical2015-01-07
KangLi pedical screw spinal system (K142290)Suzhou Kangli Orthopaedics Instrument Co., Ltd.2014-11-24
GENERAL SPINAL SYSTEM (K134011)Changzhou Dean Medical Instrument Co, Ltd.2014-09-03
SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM (K133575)Spinevision S.A.2014-06-30
KANGLI PEDICLE SCREW SPINAL SYSTEM (K140053)Suzhou Kangli Orthopaedics Instrument Co., Ltd.2014-06-26
INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS (K141376)Nexxt Spine, LLC2014-06-26
COSMOLOCK PEDICLE SCREW SYSTEM (K140678)Kalitec Direct, LLC2014-06-19
PLS (POSTERIOR LUMBAR SYSTEM) (K140787)Sintea Plustek, LLC2014-05-30
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM (K140948)Spineart2014-05-20
SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM (K133153)Spinefrontier, Inc.2014-05-14
TRUE SPINAL FUSSION SYSTEM (K133690)Innovative Surgical Designs2014-05-07
PRESSON SPINAL FIXATION SYSTEM (K133287)Nexus Spine, LLC2014-02-25
ANNEXTM ADJACENT LEVEL SYSTEM (K132403)Spine Wave, Inc.2014-01-10
PERFIX ILIAC SCREW SYSTEM (K132218)U&I Corporation2013-12-17
ANAX 5.5 SPINAL SYSTEM (K132101)U&I Corporation2013-11-25
OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM (K131810)Osseus Fusion Systems, LLC2013-08-08
CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM (K131538)Captiva Spine2013-08-08
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM (K130267)Spineart2013-05-31
INTRAMEDULLARY NAIL SYSTEM (K122994)Weigao Orthopaedic Device Co., Ltd.2013-04-12
GSO GS1 CANNULATED SCREW SYSTEM (K123487)Gold Standard Orthopaedics, LLC2013-03-11
SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM (K123164)Spinefrontier, Inc.2013-02-15
MEGA 5.5 SPINE SYSTEM (K123476)Lsk Biopartners, Inc.2013-01-08
INSTINCT JAVA SYSTEM (K122592)Zimmer Spine2013-01-04
GALLEON PEDICLE SCREW SYSTEM (K122814)Everest Spine, LLC2012-12-03
FORTEX PEDICLE SCREW SYSTEM (K120832)X-Spine Systems, Inc.2012-10-23
RANGE SPINAL SYSTEM (MESA AND DENALI) (K121016)K2m, Inc.2012-06-27
LDR SPINE SPINETUNE TL SPINAL SYSTEM (K120760)Ldr Spine USA, Inc.2012-06-27
S 100 PEDICLE SCREW SYSTEM (K111940)Renovis Surgical Technologies, LLC2012-05-15
SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM (K120353)Bm Korea Co., Ltd.2012-05-09
DSS STABILIZATION SYSTEM-RIGID (K120491)Paradigm Spine, LLC2012-05-09
ARTS2 SPINAL FIXATION SYSTEM (K103573)Advanced Medical Technologies2011-12-28
LANCER PEDICLE SCREW SYSTEM (K110633)Spinal Solutions, LLC2011-12-15
XINGTM SPINE SYSTEM (K111995)Implanova Co., Ltd.2011-12-12
DEVINE SPINAL SYSTEM (K111690)Changzhou Orthmed Medical Instrument Co., Ltd.2011-11-22
PASS LP SPINAL SYSTEM (K110497)Medicrea International2011-09-26
ODALYS PEDICLE SCREW SYSTEM (K111370)Kalitec Direct, LLC2011-09-21
REXIOUS SPINAL FIXATION SYSTEM (K111362)Dio Medical Co., Ltd.2011-07-21
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM (K102458)Solco Biomedical Co., Ltd.2011-06-13
TIGER SPINE SYSTEM (K110321)Corelink, LLC2011-05-25
AAXTER A3 POSTERIOR SPINAL SYSTEM (K101374)Aaxter Co., Ltd.2011-03-16
PALLA M SPINAL SYSTEM (K102574)Korea Bone Bank Co., Ltd.2011-03-07
ZENITH PEDICLE SYSTEM (K102636)Apollo Spine, Inc.2011-03-03
4CIS VANE SPINE SYSTEM (K101818)Solco Biomedical Co., Ltd.2011-02-11
VENUS BASIC SPINAL FIXATION SYSTEM (K103085)L&K BIOMED Co., Ltd.2011-02-09
FLAMENCO SPINAL FIXATION SYSTEM (K102853)Ulrich GmbH & Co. KG2011-01-25
EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM (K102870)Exactech, Inc.2011-01-21
EMERALD SPINAL SYSTEM (K101446)Mazor Surgical Technologies , Ltd.2011-01-20
INERTIA PEDICLE SCREW SYSTEM (K101278)Nexxt Spine, LLC2010-12-20
APEX SPINE SYSTEM W/ COCR RODS (K102488)Spinecraft, LLC2010-12-10
QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM (K093771)Pioneer Surgical Technology2010-08-10
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM (K101678)Spineart2010-07-28
VENUS BASIC SPINAL FIXATION SYSTEM (K100706)L&K BIOMED Co., Ltd.2010-07-22
SPONDY SPINAL FIXATION SYSTEM (K100956)Allure Spine LLC2010-07-09
TYCHE PEDICLE SCREW SYSTEM (K100373)Kyung Won Medical Co., Ltd.2010-06-30
MIS SYSTEM (K100605)Spine Wave, Inc.2010-06-04
MODIFICATION TO: OASYS SYSTEM (K093670)Stryker Spine2010-03-18
MODIFICATION TO CAPSURE PS SYSTEM (K100122)Spine Wave, Inc.2010-02-12
PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549) (K091725)U&I Corp.2009-11-09
NORM SPINAL SYSTEM (K092011)Norm Tibbi Urunler Ithalat Ihracat Sanayi VE Ticar2009-10-28
ULC SPINAL PEDICLE SCREW SYSTEM (K083077)Otis Biotech Co., Ltd.2009-10-26
GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW (K083567)Co-Ligne AG2009-09-14
FORTEX PEDICLE SCREW SYSTEM (K090224)X-Spine Systems, Inc.2009-07-30
ALPINE PEDICLE SCREW SYSTEM (K090477)Sanacor2009-07-27
SPINAL EDGE TITAN PEDICLE SCREW SYSTEM (K091110)Spinal Edge, LLC2009-07-24
DVX SPINE SYSTEM (K090424)Bk Meditech, Co., Ltd.2009-05-14
ROC LUMBAR PLATING SYSTEM (K090228)Alphatec Spine, Inc.2009-04-29
LANX SPINAL FIXATION SYSTEM (K083581)Lanx, Inc.2009-04-07
MESA SPINAL SYSTEM (K080611)K2m, Inc.2009-03-04
NOVEL SPINAL SYSTEM (K081153)Medyssey Co, Ltd.2009-01-30
LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM (K083826)Allez Spine, LLC2009-01-22
ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM (K081165)Spineart2008-12-17
EOS SPINAL SYSTEM (K082509)Korea Bone Bank Co., Ltd.2008-12-15
PASS LP SPINAL SYSTEM (K082577)Medicrea Technologies2008-10-03
MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM (K081883)Us Spine2008-09-24
4CIS SOLAR AND APOLLON SPINE SYSTEMS (K082453)Solco Biomedical Co., Ltd.2008-09-23
FIXXSURE CROSS LINK (K081331)Spineworks, LLC2008-07-23
SINTEA BIOTECH PLS MULTI-AXIAL SCREWS (K081631)Sintea Biotech, Inc.2008-07-18
GPS, G SURGICAL PEDICLE SYSTEM (K081041)G Surgical Co., Ltd.2008-06-27
MOUNTAINEER OCT SPINAL SYSTEM (K080828)Depuy Spine, Inc.2008-06-27
RANGE SPINAL SYSTEM, LARGE DENALI SCREWS (K081381)K2m, Inc.2008-06-13
PREFERENCE PEDICLE SCREW SYSTEM (K081296)Us Spine2008-06-06
DVX SPINE SYSTEM (K080876)Bk Meditech, Co., Ltd.2008-06-04
ACCIN PEDICLE SCREW SYSTEM (K073531)Accelerated Innovation, LLC2008-02-04
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Every clearance here is in the API, with alerts when new ones post.