FDA.reportPublic FDA data

Spinal dynamic-stabilization system

Definition
A sterile bone screw spinal implant assembly intended to be used for spinal dynamic stabilization (i.e., soft stabilization), a surgical method different from spinal fixation in that it allows slight mobility between the unstable vertebral segments in the spine. It consists of a combination of pedicle screws, spacers, and a flexible synthetic polymer cord and titanium (Ti) rods used as the longitudinal member; conventional and specialized surgical instruments may also be included. The system is intended to treat various lumbar, thoracic, and/or sacral spinal instabilities and deformities (e.g., degenerative spondylolisthesis, pseudoarthrosis) typically as an adjunct to spinal fusion.
GUDID devices
333
Last updated
2022-06-22 22:08:07

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00763000198343Anteralign Spinal System with Titan nanoLock Surface technologyMEDTRONIC SOFAMOR DANEK, INC.465112102022-06-10
00887868227325The Tether™ZIMMER BIOMET INC230H10012021-09-13
00887868227332The Tether™ZIMMER BIOMET INC230H10022021-09-13
00887868227394The Tether™ZIMMER BIOMET INC230H30022021-09-13
00887868227486The Tether™ZIMMER BIOMET INC230H60062021-09-13
00887868531828The Tether™ZIMMER BIOMET INC211H00012021-09-13
07290018128411Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDExtender- Lenke 1 Left2021-06-29
07290014993808Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDMID-C Surgical Instruments Kit2020-05-24
07290018128008Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDMID-C 85 2020-05-24
07290018128015Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDMID-C 952020-05-24
07290018128022Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDMID-C 105 2020-05-24
07290018128039Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDMID-C 115 2020-05-24
07290018128046Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDMID-C 1252020-05-24
07290018128053Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDScrew 5.0 X 302020-05-24
07290018128060Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDScrew 5.0 X 352020-05-24
07290018128077Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDScrew 5.5 X 302020-05-24
07290018128084Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDScrew 5.5 X 352020-05-24
07290018128091Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDScrew 5.5 X 40 2020-05-24
07290018128107Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDScrew 5.5 X 45 2020-05-24
07290018128114Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDScrew 6.0 X 352020-05-24
07290018128121Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDScrew 6.0 X 402020-05-24
07290018128138Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDScrew 6.0 X 452020-05-24
07290018128145Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDScrew 6.5 X 35 2020-05-24
07290018128152Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDScrew 6.5 X 40 2020-05-24
07290018128169Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDScrew 6.5 X 452020-05-24
07290018128176Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDScrew 6.5 X 502020-05-24
07290018128183Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDScrew 7.0 X 402020-05-24
07290018128190Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDScrew 7.0 X 45 2020-05-24
07290018128206Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDScrew 7.0 X 502020-05-24
07290018128213Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDLP Screw 5.0 X 30 2020-05-24
07290018128220Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDLP Screw 5.0 X 35 2020-05-24
07290018128237Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDLP Screw 5.5 X 302020-05-24
07290018128244Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDLP Screw 5.5 X 352020-05-24
07290018128251Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDLP Screw 5.5 X 402020-05-24
07290018128268Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDLP Screw 5.5 X 452020-05-24
07290018128275Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDLP Screw 6.0 X 352020-05-24
07290018128282Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDLP Screw 6.0 X 402020-05-24
07290018128299Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDLP Screw 6.0 X 452020-05-24
07290018128305Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDLP Screw 6.5 X 35 2020-05-24
07290018128329Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDLP Screw 6.5 X 45 2020-05-24
07290018128336Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDLP Screw 6.5 X 502020-05-24
07290018128343Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDLP Screw 7.0 X 402020-05-24
07290018128350Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDLP Screw 7.0 X 452020-05-24
07290018128367Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDLP Screw 7.0 X 50 2020-05-24
07290018128374Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDExtender - Lenke 52020-05-24
07290018128381Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDExtender - Lenke 12020-05-24
07290018128398Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDTUS-022-STR2020-10-28
07290018128404Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTDTUS-023-STR2020-10-28
07290018128312Minimally Invasive Deformity Correction (MID-C) SystemAPIFIX LTD LP Screw 6.5 X 402020-05-25
00889024283688Dynesys®Zimmer GmbH01.03710.0062015-10-16
00889024283695Dynesys®Zimmer GmbH01.03710.6452016-03-14
00889024283701Dynesys®Zimmer GmbH01.03711.1002016-03-14
00889024283718Dynesys®Zimmer GmbH01.03711.2002016-03-14
00889024283725Dynesys®Zimmer GmbH01.03715.2352015-10-16
00889024283732Dynesys®Zimmer GmbH01.03716.0352015-10-16
00889024283749Dynesys®Zimmer GmbH01.03716.0402015-10-16
00889024283756Dynesys®Zimmer GmbH01.03716.0452015-10-16
00889024283763Dynesys®Zimmer GmbH01.03716.0502015-10-16
00889024283770Dynesys®Zimmer GmbH01.03716.4352015-10-16
00889024283787Dynesys®Zimmer GmbH01.03716.4402015-10-16
00889024283794Dynesys®Zimmer GmbH01.03716.4452015-10-16
00889024283800Dynesys®Zimmer GmbH01.03716.4502015-10-16
00889024283817Dynesys®Zimmer GmbH01.03716.4552015-10-16
00889024283824Dynesys®Zimmer GmbH01.03717.2352015-10-16
00889024283831Dynesys®Zimmer GmbH01.03717.2402015-10-16
00889024283848Dynesys®Zimmer GmbH01.03717.2452015-10-16
00889024283855Dynesys®Zimmer GmbH01.03717.2502015-10-13
00889024283862Dynesys®Zimmer GmbH01.03717.2552015-10-16
00889024283879Dynesys®Zimmer GmbH01.03718.0352015-10-16
00889024283886Dynesys®Zimmer GmbH01.03718.0402015-10-16
00889024283893Dynesys®Zimmer GmbH01.03718.0452015-10-16
00889024283909Dynesys®Zimmer GmbH01.03718.0502015-10-16
00889024283916Dynesys®Zimmer GmbH01.03718.0552015-10-16
00889024284128Zimmer® DTO®Zimmer GmbH01.03791.0402015-10-16
00889024284135Zimmer® DTO®Zimmer GmbH01.03791.0502015-10-16
00889024284142Zimmer® DTO®Zimmer GmbH01.03791.0602015-10-16
00889024284159Zimmer® DTO®Zimmer GmbH01.03791.0702015-10-16
00889024284166Zimmer® DTO®Zimmer GmbH01.03791.0802015-10-16
00889024284173Zimmer® DTO®Zimmer GmbH01.03791.0902015-10-16
00889024284180Zimmer® DTO®Zimmer GmbH01.03791.1002015-10-16