FDA.reportPublic FDA data

Spinal bone set screw

Definition
A small, threaded, implantable, non-bioabsorbable disc intended to be threaded into the proximal end of a spinal bone screw (screw head), anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy).
GUDID devices
135
Last updated
2024-09-06 08:47:31

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
M824SMPH95T30XL1APEX Spine SystemSPINECRAFT, LLCS-MPH95-T30XL2014-09-24
08809493854648MEGA PLUS SPINE SYSTEMBK MEDITECH CO.,LTD.931102018-03-23
08809493854655MEGA PLUS SPINE SYSTEMBK MEDITECH CO.,LTD.931202018-03-23
08809493854662MEGA PLUS SPINE SYSTEMBK MEDITECH CO.,LTD.935012018-03-23
M824SS6T30L1APEX Spine SystemSPINECRAFT, LLCSS6-T30L2017-12-03
M824SS6T30XL1APEX Spine SystemSPINECRAFT, LLCSS6-T30XL2017-12-03
M824SS6F258T201APEX Spine SystemSPINECRAFT, LLCSS6-F258-T202014-09-24
M824SS6MPH95T301APEX Spine SystemSPINECRAFT, LLCSS6-MPH95-T302014-09-24
M824SS6MPH95T30L1APEX Spine SystemSPINECRAFT, LLCSS6-MPH95-T30L2014-09-24
M824SS6T20C1APEX Spine SystemSPINECRAFT, LLCSS6-T20C2017-12-03
M824SS6T20F1APEX Spine SystemSPINECRAFT, LLCSS6-T20F2017-12-03
M824SS6T301APEX Spine SystemSPINECRAFT, LLCSS6-T302017-12-03
08809155852289DVX SPINE SYSTEMBK MEDITECH CO.,LTD.811102015-09-22
08809155856904MEGA SPINE SYSTEMBK MEDITECH CO.,LTD.611102015-09-22
08809228125579MEGA5.5 SPINE SYSTEMBK MEDITECH CO.,LTD.635202015-09-22
08809228126460DVX5.5 SPINE SYSTEMBK MEDITECH CO.,LTD.821102015-09-22
10705034595542TRIALTISMedos International Sàrl5560-01-00X4S2024-08-16
10705034595887TRIALTISMedos International Sàrl5560-01-00X8S2024-08-16
10705034596891TRIALTISMedos International Sàrl5560-01-00X2S2024-08-16
10705034596907TRIALTISMedos International Sàrl5560-01-00X6S2024-08-16
00193082083174ASTRA-OCT Spine SystemSPINECRAFT, LLCA3S-T152018-10-03
00193082083181ASTRA-OCT Spine SystemSPINECRAFT, LLCA3S-T15C2018-10-03
00193082083198ASTRA-OCT Spine SystemSPINECRAFT, LLCA3S-T15F2018-10-03
00193082083204ASTRA-OCT Spine SystemSPINECRAFT, LLCA3S-XN2018-10-03
00193082083211ASTRA-OCT Spine SystemSPINECRAFT, LLCA3S-XT152018-10-03
M824A5ST22C1ASTRA Spine SystemSPINECRAFT, LLCA5S-T22C2015-09-11
M824A5ST22F1ASTRA Spine SystemSPINECRAFT, LLCA5S-T22F2015-09-11
M824A5ST301ASTRA Spine SystemSPINECRAFT, LLCA5S-T302015-09-11
08800043934490N/ATDM Co., Ltd.1054-00012022-09-15
00889929006177Inertia® Pedicle Screw SystemNEXXT SPINE, LLC10-4-0002015-09-10
00889929006184Inertia® Pedicle Screw SystemNEXXT SPINE, LLC10-4-0012015-09-10
00889929019818SAXXONY™ Posterior Cervical Thoracic SystemNEXXT SPINE, LLC12-LC-012018-12-04
00889929019863SAXXONY™ Posterior Cervical Thoracic SystemNEXXT SPINE, LLC12-LC-052018-12-04
00889929019870SAXXONY™ Posterior Cervical Thoracic SystemNEXXT SPINE, LLC12-LC-062018-12-04
00889929026793Inertia® Pedicle Screw and Deformity Correxxion® SystemNEXXT SPINE, LLC10-4-0032018-08-22
10705034070087EXPEDIUMMedos International Sàrl1797220502015-09-24
10705034466132EXPEDIUM VERSEMedos International Sàrl1997210002015-09-24
10705034030036EXPEDIUMMedos International Sàrl1754302002015-09-24
10705034032443EXPEDIUMMedos International Sàrl1754910402015-09-24
10705034032467EXPEDIUMMedos International Sàrl1754911502015-09-24
10705034034058MOSSDEPUY SPINE, LLC1755650102015-09-24
10705034059792MONARCHDEPUY SPINE, LLC1770910752015-09-24
10705034064307EXPEDIUMMedos International Sàrl1797020002015-09-24
10705034070070EXPEDIUMMedos International Sàrl1797220002015-09-24
10705034077277EXPEDIUMDEPUY SPINE, LLC1797610002015-09-24
10705034077536EXPEDIUMDEPUY SPINE, LLC1797710002015-09-24
10705034084664EXPEDIUMMedos International Sàrl1799020002015-09-24
10705034088907EXPEDIUMMedos International Sàrl1799220002015-09-24
10705034103846EXPEDIUMDEPUY SPINE, LLC1861000012015-09-24
10705034103853EXPEDIUMDEPUY SPINE, LLC1861000022015-09-24
10705034103860EXPEDIUMDEPUY SPINE, LLC1861000032015-09-24
10705034103907EXPEDIUMDEPUY SPINE, LLC1861000072015-09-24
10705034109237EXPEDIUMDEPUY SPINE, LLC1861728402015-09-24
10705034109251EXPEDIUMDEPUY SPINE, LLC1861728552015-09-24
10705034138336EXPEDIUMDEPUY SPINE, LLC1877010152015-09-24
10705034139036EXPEDIUMDEPUY SPINE, LLC1877040052015-09-24
10705034144405EXPEDIUMDEPUY SPINE, LLC1881020002015-09-24
10705034144412EXPEDIUMDEPUY SPINE, LLC1881020052015-09-24
10705034152523EXPEDIUMMedos International Sàrl1881610002015-09-24
10705034169590EXPEDIUM SFXDEPUY SPINE, LLC1894050002015-09-24
10705034169613EXPEDIUM SFXDEPUY SPINE, LLC1894070002015-09-24
10705034171579EXPEDIUMMedos International Sàrl1896020002015-09-24
10705034240640ISOLADEPUY SPINE, LLC203007R2015-09-24
10705034241470TIMXDEPUY SPINE, LLC325005SS2015-09-24
10705034251271EXPEDIUMMedos International Sàrl1754301002015-09-24
10705034253800EXPEDIUMMedos International Sàrl1754910452015-09-24
10705034265063EXPEDIUMMedos International Sàrl179702000S2016-11-18
10705034278322EXPEDIUMDEPUY SPINE, LLC1861770302015-09-24
10705034278339EXPEDIUMDEPUY SPINE, LLC1861770332015-09-24
10705034466156EXPEDIUM VERSEMedos International Sàrl1997210012015-09-24
10705034514055SYMPHONYMedos International Sàrl1020-23-0022019-08-02
10705034514352SYMPHONYMedos International Sàrl1020-00-0002019-08-02
10705034514369SYMPHONYMedos International Sàrl1020-23-0012019-08-02
10705034520445SYMPHONYMedos International Sàrl1020-23-001S2019-08-02
10705034520452SYMPHONYMedos International Sàrl1020-23-002S2019-08-02
10705034526799SYMPHONYMedos International Sàrl1020-00-000S2019-08-02
10705034531854SYMPHONYMedos International Sàrl1020-00-003S2019-08-02
M7406405000Fortress Set ScrewSPINEOLOGY INC.10-10-53-12014-12-05
M7406406000Fortress Set ScrewSPINEOLOGY INC.10-10-53-22014-12-05
M7406700001Palisade Pedicular Fixation SystemSPINEOLOGY INC.10-10-622016-03-01