Atlas FDA

MNI

303 FDA 510(k) clearances · Product code

73 daysmedian time to decision
224 days90th percentile
303clearances measured

FDA profile

Official device name
Orthosis, Spinal Pedicle Fixation
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3070
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 270 · 2022: 214 · 2023: 122 · 2024: 114 · 2025: 81 · 2026: 23
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
Mikron Spinal Fixation System (K171497)Mikron Makina Sanayi Ticaret Co. , Ltd.2017-10-12
LumFix Spinal Fixation Sytem (K160731)CG Bio Co., Ltd.2016-10-04
Double Medical Universal Spine System (K151458)Double Medical Technology, Inc.2016-08-22
MySpine Pedicle Screw Placement Guides - LP (K153273)Medacta International S.A.2016-06-29
LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System (K160124)Spinevision S.A.2016-04-04
Premier (K160320)Shandong Weigao Orthopaedic Device Co., Ltd.2016-04-01
Sniper (R) Spine System (K160003)Spine Wave, Inc.2016-02-26
YAHUA Spinal System (K152324)Beijing Weigao Yahua Artificial Joint Development Co. , Ltd.2016-02-01
FIREFLY Pedicle Screw Navigation Guide (K143222)Mighty Oak Medical, Inc.2015-12-11
WASTON General Spinal System (K150684)Changzhou Waston Medical Appliance Co., Ltd.2015-11-18
X-spine Pedicle Screw System (K152132)X-Spine Systems, Inc.2015-09-25
Gemmed pedicle screw spinal system (K151592)Suzhou Gemmed Medical Instrument Co., Ltd.2015-09-24
ODALYS Pedicle Screw System (K152098)Kisco International2015-09-17
Reliance Spinal Screw System (K152131)Reliance Medical Systems, LLC2015-09-17
Sniper Spine System (K152174)Spine Wave, Inc.2015-08-31
Sniper Spine System (K151813)Spine Wave, Inc.2015-07-31
DPZ Pedicular Fixation System (K150294)Osteomed Implantes, Ltda2015-06-05
Polyscrew Pedicle Screw System (K150647)New Era Orthopedics, LLC2015-04-08
PASS LP Spinal System (K150049)Medicrea International2015-02-10
NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM (K141253)New Era Orthopaedics, LLC2015-01-09
PASS LP SPINAL SYSTEM (K140738)Medicrea International2014-11-04
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODS (K141835)Spineart2014-09-10
SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM (K141397)Precision Spine, Inc.2014-06-26
MYSPINE PEDICLE SCREW PLACEMENT GUIDES (K132788)Medacta International2014-05-23
GENERAL SPINAL SYSTEM (K140229)Tianjin Walkman Biomaterial Co., Ltd.2014-04-29
AVERSION PEDICLE SCREW SYSTEM (K133103)K7, LLC2014-01-27
MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS (K130073)Mikron Makina Sanayi VE Ticaret Ltd. Sti.2013-12-16
EVEREST SPINAL SYSTEM (K132757)K2m, Inc.2013-11-20
ALTUS SPINE PEDICLE SCREW SYSTEM (K132280)Altus Partners2013-10-31
TRUE SPINAL FIXATION SYSTEM (K130958)Innovative Surgical Designs2013-10-17
INERTIA MIS PEDICLE SCREW SYSTEM (K132412)Nexxt Spine, LLC2013-10-10
EVEREST SPINAL SYSTEM (K132361)K2m, Inc.2013-10-03
LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU (K132644)Corentec Co., Ltd.2013-09-19
SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION (K132365)Accel Spine2013-08-20
CORE PEDICLE SCREW SYSTEM (K131522)Core-Nexus2013-08-09
CAPSURE PS SYSTEM (K132154)Spine Wave, Inc.2013-08-09
SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT (K130302)Spinevision S.A.2013-07-30
REFORM PEDICLE SCREW SYSTEM (K131343)Spinal USA2013-07-24
REFORM PEDICLE SCREW SYSTEM (K130279)Spinal USA2013-06-20
RELIANCE SPINAL SCREW SYSTEM (K123521)Reliance Medical Systems, LLC2013-02-07
S-LOK PSS SYSTEM (K122931)Spinal USA2012-11-20
CERTEX SPINAL IMPLANT SYSTEM (K122163)X-Spine Systems, Inc.2012-10-31
TOWERLOX PEDICLE SCREW SYSTEM (K122332)Captiva Spine2012-10-16
CAPSURE(R) PS SYSTEM (K122233)Spine Wave, Inc.2012-10-11
4CIS VANE SPINE SYSTEM (K121615)Solco Biomedical Co., Ltd.2012-08-15
REFORM PEDICLE SCREW SYSTEM (K121172)Spinal USA2012-08-08
CAPSURE(R) PS SYSTEM (K120646)Spine Wave, Inc.2012-06-07
RANGE SPINAL SYSTEM, UNIT ROD (K120899)K2m, Inc.2012-05-25
LEXUS CERVICAL FIXATION SYSTEM (K120879)L&K BIOMED Co., Ltd.2012-05-23
RANGE SPINAL SYSTEM (MESA AND DENALI) (K120099)K2m, Inc.2012-05-18
SINTEA PLUSTEK PLS MULTI-AXIAL SCREWS (K112611)Sintea Plastek, LLC2012-04-25
CAPLOX II PEDICLE SCREW SYSTEM (K120292)Captiva Spine, Inc.2012-04-13
EVEREST SPINAL SYSTEM (K120656)K2m, Inc.2012-04-04
TIGER SPINE SYSTEM (K120696)Corelink, LLC2012-04-02
PALLS M SPINAL SYSTEM (K120538)Korea Bone Bank Co., Ltd.2012-03-23
AILERON INTERSPINOUS FIXATION SYSTEM (K113157)Life Spine2012-03-13
SAVANNAH TECHNOLOGIES SPINAL SYSTEM (K113755)Savannah Technologies, LLC2012-02-01
SYNTHES USS CONNECTORS (K113149)Synthes Spine2012-02-01
RELIANCE SPINAL SCREW SYSTEM (K110896)Reliance Medical Systems, LLC2012-01-20
RANGE SPINAL SYSTEM (MESA AND DENALI) (K112920)K2m, Inc.2011-12-21
ZAVATION SPINAL SYSTEM (K112484)Zavation, LLC2011-11-22
PASS LP SPINAL SYSTEM (K112493)Medicrea International2011-11-21
SMARTLOC SPINAL FIXATION SYSTEM (K111883)A-Spine Asia, Co., Ltd.2011-10-18
RANGE SPINAL SYSTEM (MESA AND DENALI) (K112037)K2m, Inc.2011-10-06
CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM (K111115)Captiva Spine, Inc.2011-09-13
CAPSURE(R) PS SYSTEM (K111913)Spine Wave, Inc.2011-08-31
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM (K112108)Spineart2011-08-19
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM (K111127)Spineart2011-08-11
MESA SPINAL SYSTEM (KEYSTONE RODS) (K110991)K2m, Inc.2011-08-02
VENUS CERVICAL SPINAL FIXATION SYSTEM (K103414)L&K BIOMED Co., Ltd.2011-07-22
EXACTECH GIBRALT SPINAL SYSTEM (K110197)Exactech, Inc.2011-07-15
NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM (K110284)Medyssey Co, Ltd.2011-06-08
ZENIUS SPINAL SYSTEM (K110283)Medyssey Co, Ltd.2011-05-19
EVEREST SPINAL SYSTEM (K103440)K2m, Inc.2011-03-17
LEUCADIA PEDICLE SCREW SYSTEM (K103102)Phygen, LLC2011-02-08
TALON SPINAL SYSTEM (K102995)Spine3602011-02-02
ZENIUS SPINAL SYSTEM (K103272)Medyssey Co, Ltd.2010-12-29
NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM (K103147)Medyssey Co, Ltd.2010-12-16
S 100 PEDICLE SCREW SYSTEM (K101682)Renovis Surgical Technologies, LLC2010-12-07
MOUNTAINEER OCT SPINAL SYSTEM (K103100)Depuy Spine, Inc.2010-11-17
LIFE SPINE INTERSPINOUS FIXATION SYSTEM (K100407)Life Spine2010-11-05
KAPSS SPINAL SYSTEM (K093833)Robert Reid, Inc.2010-10-15
LDR SPINE USA SPINETUNE TL SPINAL SYSTEM (K102331)Ldr Spine USA2010-10-15
RANGE SPINAL SYSTEM (K100851)K2m, Inc.2010-08-02
FIXPINE II SYSTEM (K100765)Dio Medical Co., Ltd.2010-07-19
MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM (K093104)Medyssey Co, Ltd.2010-06-25
DIAMONDBACK SPINAL SYSTEM (K100377)Eminent Spine2010-04-22
AEGIS & AEGIS II SPINAL SYSTEM (K092076)Corentec Co., Ltd.2010-04-02
LDR SPINE USA SPINE TUNE TL SPINE SYSTEM (K100575)Ldr Spine USA2010-03-31
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM (K093936)Spineart2010-03-11
PASS LP SPINAL SYSTEM (K100297)Medicrea Technologies2010-03-04
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM (K100138)Alphatec Spine, Inc.2010-02-17
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM (K093077)Alphatec Spine, Inc.2009-12-23
MODIFICATION TO LANX SPINAL FIXATION SYSTEM (K093285)Lanx, LLC2009-12-10
KRD1 PEDICLE SCREW SYSTEM (K092420)Spinefrontier, Inc.2009-11-19
CASPIAN SPINAL SYSTEM (K092640)K2m, Inc.2009-11-06
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM (K093170)Spineart2009-11-04
MODIFICATION TO: PSS SYSTEM (K092128)Spinal USA2009-09-14
PASS LP SPINAL SYSTEM (K083810)Medicrea Technologies2009-07-31
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM (K091189)Alphatec Spine, Inc.2009-07-08
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