FDA 510(k) Applications for Medical Device Product Code "GZB"
(Stimulator, Spinal-Cord, Implanted (Pain Relief))
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K022222 | ADVANCED NEUROMODULATION SYSTEM,INC | LAMITRODE S-SERIES (S4 AND S8) LEADS | 08/08/2002 |
| K030461 | ADVANCED NEUROMODULATION SYSTEMS | A127 LEAD EXTENSION | 04/24/2003 |
| K053250 | ADVANCED NEUROMODULATION SYSTEMS | ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT | 12/15/2005 |
| K032034 | ADVANCED NEUROMODULATION SYSTEMS | ANS AXXESS PERCUTANEOUS LEAD | 10/03/2003 |
| K050922 | ADVANCED NEUROMODULATION SYSTEMS | ANS SCS ACCESSORY KIT | 05/18/2005 |
| K052418 | ADVANCED NEUROMODULATION SYSTEMS | AXXESS BUTTERFLY ANCHOR | 09/26/2005 |
| K081208 | ADVANCED NEUROMODULATION SYSTEMS | CINCH ANCHOR, MODEL 1194 | 07/18/2008 |
| K990469 | ADVANCED NEUROMODULATION SYSTEMS | LAMITRODE LEADS | 06/03/1999 |
| K033429 | ADVANCED NEUROMODULATION SYSTEMS | LAMITRODE SPINAL CORD STIMULATION LEADS | 12/04/2003 |
| K030674 | ADVANCED NEUROMODULATION SYSTEMS | MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD | 03/28/2003 |
| K032751 | ADVANCED NEUROMODULATION SYSTEMS | MODIFICATION TO RENEW LEAD EXTENSION | 10/06/2003 |
| K033757 | ADVANCED NEUROMODULATION SYSTEMS | MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM | 01/30/2004 |
| K021518 | ADVANCED NEUROMODULATION SYSTEMS | PAINDOC | 06/06/2002 |
| K090907 | ADVANCED NEUROMODULATION SYSTEMS | PENTA LEAD KITS, MODELS: 3227-3234 | 06/02/2009 |
| K032349 | ADVANCED NEUROMODULATION SYSTEMS | PLACER | 10/03/2003 |
| K052374 | ADVANCED NEUROMODULATION SYSTEMS | RAPID PROGEAMMER 3.0 | 11/22/2005 |
| K030118 | ADVANCED NEUROMODULATION SYSTEMS | RAPID PROGRAMMAR | 03/11/2003 |
| K040609 | ADVANCED NEUROMODULATION SYSTEMS | RAPID PROGRAMMER | 03/25/2004 |
| K991784 | ADVANCED NEUROMODULATION SYSTEMS | RENEW LEAD EXTENSION | 06/24/1999 |
| K992946 | ADVANCED NEUROMODULATION SYSTEMS | RENEW RECEIVER | 09/24/1999 |
| K092371 | ADVANCED NEUROMODULATION SYSTEMS | SWIFT-LOCK ANCHOR, MODEL 1192 | 12/23/2009 |
| K050633 | ADVANCED NEUROMODULATION SYSTEMS | TRIAL CABLE RETENTION CLIP | 04/21/2005 |
| K070847 | ADVANCED NEUROMODULATION SYSTEMS | TRIAL CABLE, 3009 | 04/11/2007 |
| K063080 | ADVANCED NEUROMODULATION SYSTEMS | TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS | 12/12/2006 |
| K072462 | ADVANCED NEUROMODULATION SYSTEMS | WIDE SPACED QUATTRODE LEADS | 10/11/2007 |
| K091993 | ADVANCED NEUROMODULATION SYSTEMS, INC. (ANS INC.) | RAPID PROGRAMMER, VERSION 3.3.0 | 07/31/2009 |
| K150924 | ANCHOR INNOVATION MEDICAL (A.I.M.) | 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/Sut | 07/27/2015 |
| K111462 | ANULEX TECHNOLOGIES, INC | FIXATE TISSUE BAND | 09/08/2011 |
| K112849 | ANULEX TECHNOLOGIES, INC | FIXATE TISSUE BAND | 10/27/2011 |
| K113400 | ANULEX TECHNOLOGIES, INC | FIXATE TISSUE BAND | 12/16/2011 |
| K113805 | ANULEX TECHNOLOGIES, INC | FIXATE TISSUE BAND | 02/23/2012 |
| K994097 | MEDAMICUS, INC. | MEDAMICUS EPIDURAL INTRODUCER | 03/01/2000 |
| K013120 | MEDAMICUS, INC. | PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18 | 01/24/2002 |
| K062041 | MEDTRONIC INC. | MODEL 3875 1 X 8 SC TEST STIMULATION LEAD | 08/16/2006 |
| K102523 | MEDTRONIC INC. | MULTI-LEAD TRIALING CABLE MODEL 355531 | 10/26/2010 |
| K051773 | MEDTRONIC INC.,NEUROLOGICAL DIVISION | MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADS | 07/28/2005 |
| K013063 | MEDTRONIC NEUROLOGICAL | GRIP LOCK ANCHOR, MODEL 411374 | 12/11/2001 |
| K033016 | MEDTRONIC NEUROLOGICAL | PISCES Z QUAD LEAD MODEL, 3890, PISCES Z QUAD COMPACT LEAD MODEL, 3891, PISCES Z QUAD PLUS LEAD MODEL, 3892 | 10/30/2003 |
| K953742 | MEDTRONIC VASCULAR | BIFURCATED Y-EXTENSION | 11/19/1996 |
| K955291 | MEDTRONIC VASCULAR | DUALSCREEN | 05/17/1996 |
| K972043 | MEDTRONIC VASCULAR | MEDTRONIC MODEL 3273/3274 RF RECEIVER AND MODEL 3629/3630 SCREENER | 08/22/1997 |
| K964172 | MEDTRONIC VASCULAR | MEDTRONIC MODEL 3991A, 3992A, 3993A, 3994A LEADS OR TRANSVERSE TRIPOLAR LEADS OR TTL | 07/03/1997 |
| K971756 | MEDTRONIC VASCULAR | MEDTRONIC MODEL 3998 LEAD | 02/03/1998 |
| K990104 | MEDTRONIC VASCULAR | MEDTRONIC MODEL 7495 EXTENSION KIT | 02/09/1999 |
| K010300 | MEDTRONIC VASCULAR | MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION | 08/01/2001 |
| K000445 | MEDTRONIC VASCULAR | MEDTRONIC MODEL 7499 EXTENSION | 04/28/2000 |
| K011584 | MEDTRONIC VASCULAR | MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF | 06/22/2001 |
| K972906 | MEDTRONIC VASCULAR | MEDTRONIC TWIST LOCK ANCHOR (PARTNUMBER 103953/3550TLA) | 02/06/1998 |
| K040568 | MEDTRONIC VASCULAR | POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS | 03/25/2004 |
| K032561 | MEDTRONIC VASCULAR | RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR | 09/11/2003 |
| K010008 | MICRONET MEDICAL, INC. | AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX | 07/16/2001 |
| K201618 | Nalu Medical, Inc | Nalu Neurostimulation SCS system | 07/15/2020 |
| K183047 | Nalu Medical, Inc | Nalu Neurostimulation System | 03/22/2019 |
| K190960 | Nalu Medical, Inc. | Nalu Lead Blank (50cm) | 07/11/2019 |
| K202274 | Nalu Medical, Inc. | 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 miscell | 11/09/2020 |
| K203547 | Nalu Medical, Inc. | Nalu Neurostimulation System | 03/25/2021 |
| K221376 | Nalu Medical, Inc. | Nalu Neurostimulation System | 06/10/2022 |
| K960728 | NEUROMED, INC. | ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE) | 05/22/1996 |
| K130545 | ST. JUDE MEDICAL | MULTI LEAD TRIAL CABLE | 06/18/2013 |
| K113611 | ST. JUDE MEDICAL | RAPID PROGRAMMER | 04/20/2012 |
| K140272 | ST. JUDE MEDICAL | SWIFT-LOCK ANCHOR | 05/02/2014 |
| K123299 | ST. JUDE MEDICAL NEUROMODULATION | MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS | 01/18/2013 |
| K112214 | ST. JUDE MEDICAL NEUROMODULATION | OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS | 11/17/2011 |
| K191466 | Stimwave Technologies Inc. | SandShark Injectable Anchor (SIA) System | 11/07/2019 |
| K182720 | Stimwave Technologies Incorporated | Freedom Spinal Cord Stimulator (SCS) System | 03/29/2019 |
| K141399 | STIMWAVE TECHNOLOGIES INCORPORATED | FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM | 10/10/2014 |
| K150517 | STIMWAVE TECHNOLOGIES INCORPORATED | Freedom Spinal Cord Stimulator System | 06/05/2015 |
| K160600 | STIMWAVE TECHNOLOGIES INCORPORATED | Freedom Spinal Cord Stimulator System | 08/26/2016 |
| K162161 | Stimwave Technologies Incorporated | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit | 12/16/2016 |
| K170141 | Stimwave Technologies Incorporated | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit | 05/02/2017 |
| K172644 | Stimwave Technologies Incorporated | Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base | 11/03/2017 |
| K180981 | Stimwave Technologies Incorporated | Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit | 09/19/2018 |
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