Atlas FDA

GZB

139 FDA 510(k) clearances · Product code

87 daysmedian time to decision
239 days90th percentile
139clearances measured

FDA profile

Official device name
Stimulator, Spinal-Cord, Implanted (Pain Relief)
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5880
Medical specialty
Neurology
Flags
Implant
Adverse events (MAUDE)
2021: 332 · 2022: 209 · 2023: 236 · 2024: 318 · 2025: 317 · 2026: 137
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation (K233801)Boston Scientific Neuromodulation2024-08-23
Nalu Neurostimulation System (K221376)Boston Scientific Neuromodulation2022-06-10
Nalu Neurostimulation System (K203547)Boston Scientific Neuromodulation2021-03-25
Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits (K202274)Boston Scientific Neuromodulation2020-11-09
Nalu Neurostimulation SCS system (K201618)Boston Scientific Neuromodulation2020-07-15
SandShark Injectable Anchor (SIA) System (K191466)Stimwave Technologies, Inc.2019-11-07
Nalu Lead Blank (50cm) (K190960)Boston Scientific Neuromodulation2019-07-11
Freedom Spinal Cord Stimulator (SCS) System (K182720)Stimwave Technologies Incorporated2019-03-29
Nalu Neurostimulation System (K183047)Boston Scientific Neuromodulation2019-03-22
Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit (K180981)Stimwave Technologies Incorporated2018-09-19
Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base (K172644)Stimwave Technologies Incorporated2017-11-03
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit (K170141)Stimwave Technologies Incorporated2017-05-02
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit (K162161)Stimwave Technologies Incorporated2016-12-16
Freedom Spinal Cord Stimulator System (K160600)Stimwave Technologies Incorporated2016-08-26
A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device (K150924)Anchor Innovation Medical (A.I.M.)2015-07-27
Freedom Spinal Cord Stimulator System (K150517)Stimwave Technologies Incorporated2015-06-05
FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM (K141399)Stimwave Technologies Incorporated2014-10-10
SWIFT-LOCK ANCHOR (K140272)St Jude Medical2014-05-02
MULTI LEAD TRIAL CABLE (K130545)St Jude Medical2013-06-18
MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS (K123299)St. Jude Medical Neuromodulation2013-01-18
RAPID PROGRAMMER (K113611)St Jude Medical2012-04-20
FIXATE TISSUE BAND (K113805)Anulex Technologies, Inc.2012-02-23
FIXATE TISSUE BAND (K113400)Anulex Technologies, Inc.2011-12-16
OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS (K112214)St. Jude Medical Neuromodulation2011-11-17
FIXATE TISSUE BAND (K112849)Anulex Technologies, Inc.2011-10-27
FIXATE TISSUE BAND (K111462)Anulex Technologies, Inc.2011-09-08
MULTI-LEAD TRIALING CABLE MODEL 355531 (K102523)Medtronic, Inc.2010-10-26
SWIFT-LOCK ANCHOR, MODEL 1192 (K092371)Advanced Neuromodulation Systems2009-12-23
RAPID PROGRAMMER, VERSION 3.3.0 (K091993)Advanced Neuromodulation Systems, Inc. (Ans Inc.)2009-07-31
PENTA LEAD KITS, MODELS: 3227-3234 (K090907)Advanced Neuromodulation Systems2009-06-02
CINCH ANCHOR, MODEL 1194 (K081208)Advanced Neuromodulation Systems2008-07-18
WIDE SPACED QUATTRODE LEADS (K072462)Advanced Neuromodulation Systems2007-10-11
TRIAL CABLE, 3009 (K070847)Advanced Neuromodulation Systems2007-04-11
TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS (K063080)Advanced Neuromodulation Systems2006-12-12
MODEL 3875 1 X 8 SC TEST STIMULATION LEAD (K062041)Medtronic, Inc.2006-08-16
ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT (K053250)Advanced Neuromodulation Systems2005-12-15
RAPID PROGEAMMER 3.0 (K052374)Advanced Neuromodulation Systems2005-11-22
AXXESS BUTTERFLY ANCHOR (K052418)Advanced Neuromodulation Systems2005-09-26
MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADS (K051773)Medtronic Inc.,Neurological Division.2005-07-28
ANS SCS ACCESSORY KIT (K050922)Advanced Neuromodulation Systems2005-05-18
TRIAL CABLE RETENTION CLIP (K050633)Advanced Neuromodulation Systems2005-04-21
POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS (K040568)Medtronic Vascular2004-03-25
RAPID PROGRAMMER (K040609)Advanced Neuromodulation Systems2004-03-25
MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM (K033757)Advanced Neuromodulation Systems2004-01-30
LAMITRODE SPINAL CORD STIMULATION LEADS (K033429)Advanced Neuromodulation Systems2003-12-04
PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCES Z QUAD PLUS LEAD MODEL, 3892 (K033016)Medtronic Neurological2003-10-30
MODIFICATION TO RENEW LEAD EXTENSION (K032751)Advanced Neuromodulation Systems2003-10-06
PLACER (K032349)Advanced Neuromodulation Systems2003-10-03
ANS AXXESS PERCUTANEOUS LEAD (K032034)Advanced Neuromodulation Systems2003-10-03
RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR (K032561)Medtronic Vascular2003-09-11
A127 LEAD EXTENSION (K030461)Advanced Neuromodulation Systems2003-04-24
MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD (K030674)Advanced Neuromodulation Systems2003-03-28
RAPID PROGRAMMAR (K030118)Advanced Neuromodulation Systems2003-03-11
LAMITRODE S-SERIES (S4 AND S8) LEADS (K022222)Advanced Neuromodulation System,Inc2002-08-08
PAINDOC (K021518)Advanced Neuromodulation Systems2002-06-06
PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18 (K013120)Medamicus, Inc.2002-01-24
GRIP LOCK ANCHOR, MODEL 411374 (K013063)Medtronic Neurological2001-12-11
MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION (K010300)Medtronic Vascular2001-08-01
AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX (K010008)Micronet Medical, Inc.2001-07-16
MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF (K011584)Medtronic Vascular2001-06-22
MEDTRONIC MODEL 7499 EXTENSION (K000445)Medtronic Vascular2000-04-28
MEDAMICUS EPIDURAL INTRODUCER (K994097)Medamicus, Inc.2000-03-01
RENEW RECEIVER (K992946)Advanced Neuromodulation Systems1999-09-24
RENEW LEAD EXTENSION (K991784)Advanced Neuromodulation Systems1999-06-24
LAMITRODE LEADS (K990469)Advanced Neuromodulation Systems1999-06-03
MEDTRONIC MODEL 7495 EXTENSION KIT (K990104)Medtronic Vascular1999-02-09
MEDTRONIC TWIST LOCK ANCHOR (PARTNUMBER 103953/3550TLA) (K972906)Medtronic Vascular1998-02-06
MEDTRONIC MODEL 3998 LEAD (K971756)Medtronic Vascular1998-02-03
MEDTRONIC MODEL 3273/3274 RF RECEIVER AND MODEL 3629/3630 SCREENER (K972043)Medtronic Vascular1997-08-22
MEDTRONIC MODEL 3991A, 3992A, 3993A, 3994A LEADS OR TRANSVERSE TRIPOLAR LEADS OR TTL (K964172)Medtronic Vascular1997-07-03
BIFURCATED Y-EXTENSION (K953742)Medtronic Vascular1996-11-19
ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE) (K960728)Neuromed, Inc.1996-05-22
DUALSCREEN (K955291)Medtronic Vascular1996-05-17
MODEL NOS. 7495 AND 501826 EXTENSIONS (K954886)Medtronic Vascular1995-11-27
PAIN DOC (K941342)Regulatory & Marketing Services, Inc.1995-10-13
MEDTRONIC MODEL 3991, 3991C, 3992, 3992C, 3993, 3993C, 3994, 3994C LEADS OR, TRANSVERSE TRIPOLAR LEADS OR, TTL (K952459)Medtronic Vascular1995-08-30
MODEL 3470 X-TREL RF RECEIVER (K943537)Medtronic Vascular1995-04-12
MEDTRONIC MATTRIX 3271/3272 NEUROSTIMULATION SYSTEM (K934065)Medtronic Vascular1995-02-14
ALTERNATE 100% ETO STERILIZATION PROCESS AND ALTERNATE STERILIZATION FACCILITY (K950127)Medtronic Vascular1995-01-30
TEMP AND PERMANENT NEURO LEADS (VARIOUS MODELS) (K945103)Medtronic Vascular1995-01-11
NEUROMED OCTRODE MODEL MNR-88A-B-C NEUROSTIM REC (K930536)Neuromed, Inc.1994-12-15
NEUROMED OCTRODE MODEL MNT-98 NEUROSTIMULATOR TRAN (K930498)Neuromed, Inc.1994-12-12
NEUROLOGICAL LEADS (PACKAGING MODIFICATION) (K940416)Medtronic Vascular1994-07-18
NEUROLOGICAL LEAD ACCESSORIES (K936099)Medtronic Vascular1994-07-11
TEMPORARY SCREENING LEAD/CATHETER KIT (K934938)Medtronic Vascular1994-06-14
MODEL 3862A & B 3863A & B TEMP. LEAD SCREENING KIT (K932202)Medtronic Vascular1994-05-04
MEDTRONIC MODEL 3625 SCREENER SYSTEM (K932948)Medtronic Vascular1994-02-03
INTRODE INT-8 (K930242)Neuromed, Inc.1994-02-02
NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-30 (K921319)Neuromed, Inc.1993-05-05
MEDTRONIC MODEL 3487A PISCES-QUAD LEAD (K923931)Medtronic Vascular1993-03-18
MEDTRONIC MODEL 3080 PISCES-QUAD LEAD (K924522)Medtronic Vascular1993-03-18
MEDTRONIC MODEL 3888 PISCES-QUAD PLUS LEAD (K923567)Medtronic Vascular1992-11-05
MEDTRONIC MODELS 3983A AND 3983B RESUME LEADS (K921558)Medtronic Vascular1992-07-07
MEDTRONIC MODELS 3982 A,B,C&D STAG ARRAY RES LEADS (K913993)Medtronic Vascular1992-02-07
MEDTRONIC MODEL 3586 RESUME LEAD (K913934)Medtronic Vascular1992-01-22
MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS (K914433)Medtronic Vascular1991-12-23
MEDTRONIC MODEL 3861 TEMPORARY SCREENING LEAD KIT (K912764)Medtronic Vascular1991-11-22
MEDTRONIC 3625 SCREENER SYSTEM (K913442)Medtronic Vascular1991-11-22
ELECTRO-NERVE STIMULATOR TENS,MODEL SYSTEMS PLUS/A (K905569)Biomedical Life Systems, Inc.1991-06-27
ANTIGENZ CHLAMYDIA (K905402)Northumbria Biologicals , Ltd.1991-03-11
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