FDA.report

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

Related Product Codes

CodeDeviceSpecialtyClassDevices
NQPPosterior Metal/Polymer Spinal System, FusionOrthopedic2281
QGPPosterior Ratcheting Rod SystemUnknownN43
QHPVertebral Body Tethering SystemUnknownN5
HWCScrew, Fixation, BoneOrthopedic21
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic21
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic21
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic21

Representative GUDID Devices

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