FDA.reportPublic FDA data

Spine thermoplastic splint system

Definition
An assembly of non-sterile devices designed to produce a thermoformable splint intended to be applied externally to the spine of a patient who requires support or immobilization (e.g., to treat fractures, injuries, sprains). It typically consists of a low-temperature thermoplastic material and a textile (e.g., cotton) in the form of the spine and into which the thermoplastic is inserted; the combination is warmed in a water bath for adaptability to the shape of the patient?s spine. It is available in various dimensions and may be used in various clinical specialties. This is a single-patient device that may be reapplied over a short term (single-use) before being discarded.
GUDID devices
79
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00817740020072BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-83002017-04-25
00817740020157BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-83052017-04-25
00817740020164BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-83102017-04-25
00817740020171BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-83152017-04-25
00817740020188BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-83202017-04-25
00817740020195BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-83252017-04-25
00817740020201BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-83302017-04-25
00817740020218BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-83352017-04-25
00817740020225BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-83402017-04-25
00817740020232BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-83452017-04-25
00817740020249BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-83502017-04-25
00817740020256BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-83552017-04-25
00817740020263BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-83602017-04-25
00817740020270BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-83652017-04-25
00817740020287BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-83702017-04-25
00817740020294BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-83752017-04-25
00817740020300BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-83802017-04-25
00817740020317BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-83852017-04-25
00817740020423BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-87402017-04-25
00817740021048BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-83312017-10-10
00645517317991TrulifeTRULIFE LIMITEDRSC100-LG-12022-12-31
00645517318004TrulifeTRULIFE LIMITEDRSC100-LG-22022-12-31
00645517318011TrulifeTRULIFE LIMITEDRSC100-LG-32022-12-31
00645517318028TrulifeTRULIFE LIMITEDRSC100-LG-42022-12-31
00645517318035TrulifeTRULIFE LIMITEDRSC100-LV-12022-12-31
00645517318042TrulifeTRULIFE LIMITEDRSC100-LV-22022-12-31
00645517318059TrulifeTRULIFE LIMITEDRSC100-LV-32022-12-31
00645517318318TrulifeTRULIFE LIMITEDRSC100-ST-12022-12-31
00645517318325TrulifeTRULIFE LIMITEDRSC100-ST-22022-12-31
00645517318332TrulifeTRULIFE LIMITEDRSC100-ST-32022-12-31
00645517318349TrulifeTRULIFE LIMITEDRSC100-ST-42022-12-31
00645517319438TrulifeTRULIFE LIMITEDRSC300-LG-12022-12-31
00645517319445TrulifeTRULIFE LIMITEDRSC300-LG-22022-12-31
00645517319452TrulifeTRULIFE LIMITEDRSC300-LG-32022-12-31
00645517319469TrulifeTRULIFE LIMITEDRSC300-LG-42022-12-31
00645517319476TrulifeTRULIFE LIMITEDRSC300-LV-12022-12-31
00645517319483TrulifeTRULIFE LIMITEDRSC300-LV-22022-12-31
00645517319490TrulifeTRULIFE LIMITEDRSC300-LV-32022-12-31
00645517319506TrulifeTRULIFE LIMITEDRSC300-LV-42022-12-31
00645517319643TrulifeTRULIFE LIMITEDRSC300-P-LG-12022-12-31
00645517319650TrulifeTRULIFE LIMITEDRSC300-P-LG-22022-12-31
00645517319667TrulifeTRULIFE LIMITEDRSC300-P-LG-32022-12-31
00645517319674TrulifeTRULIFE LIMITEDRSC300-P-LG-42022-12-31
00645517319681TrulifeTRULIFE LIMITEDRSC300-P-LV-12022-12-31
00645517319698TrulifeTRULIFE LIMITEDRSC300-P-LV-22022-12-31
00645517319704TrulifeTRULIFE LIMITEDRSC300-P-LV-32022-12-31
00645517319711TrulifeTRULIFE LIMITEDRSC300-P-LV-42022-12-31
00645517319735TrulifeTRULIFE LIMITEDRSC300-P-ST-12022-12-31
00645517318066TrulifeTRULIFE LIMITEDRSC100-LV-42022-12-31
10817740020079BIONIX RADIATION THERAPYBIONIX RADIATION THERAPY, LLCEMRT-83002017-04-25
10817740020154BIONIX RADIATION THERAPYBIONIX RADIATION THERAPY, LLCEMRT-83052017-04-25
10817740020161BIONIX RADIATION THERAPYBIONIX RADIATION THERAPY, LLCEMRT-83102017-04-25
10817740020178BIONIX RADIATION THERAPYBIONIX RADIATION THERAPY, LLCEMRT-83152017-04-25
10817740020185BIONIX RADIATION THERAPYBIONIX RADIATION THERAPY, LLCEMRT-83202017-04-25
10817740020192BIONIX RADIATION THERAPYBIONIX RADIATION THERAPY, LLCEMRT-83252017-04-25
10817740020208BIONIX RADIATION THERAPYBIONIX RADIATION THERAPY, LLCEMRT-83302017-04-25
10817740020215BIONIX RADIATION THERAPYBIONIX RADIATION THERAPY, LLCEMRT-83352017-04-25
10817740020222BIONIX RADIATION THERAPYBIONIX RADIATION THERAPY, LLCEMRT-83402017-04-25
10817740020239BIONIX RADIATION THERAPYBIONIX RADIATION THERAPY, LLCEMRT-83452017-04-25
10817740020246BIONIX RADIATION THERAPYBIONIX RADIATION THERAPY, LLCEMRT-83502017-04-25
10817740020253BIONIX RADIATION THERAPYBIONIX RADIATION THERAPY, LLCEMRT-83552017-04-25
00817740020324BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-84002017-04-25
00817740020331BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-84052017-04-25
00817740020348BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-84102017-04-25
00817740020355BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-84152017-04-25
00817740020362BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-84202017-04-25
00817740020379BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-84252017-04-25
00817740020386BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-84302017-04-25
00817740020393BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-84402017-04-25
00817740020409BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-84502017-04-25
00817740020416BIONIX RADIATION THERAPYBionix Radiation Therapy, LLCEMRT-84552017-04-25
10817740020260BIONIX RADIATION THERAPYBIONIX RADIATION THERAPY, LLCEMRT-83602017-04-25
10817740020277BIONIX RADIATION THERAPYBIONIX RADIATION THERAPY, LLCEMRT-83652017-04-25
10817740020284BIONIX RADIATION THERAPYBIONIX RADIATION THERAPY, LLCEMRT-83702017-04-25
10817740020291BIONIX RADIATION THERAPYBIONIX RADIATION THERAPY, LLCEMRT-83752017-04-25
10817740020307BIONIX RADIATION THERAPYBIONIX RADIATION THERAPY, LLCEMRT-83802017-04-25
10817740020314BIONIX RADIATION THERAPYBIONIX RADIATION THERAPY, LLCEMRT-83852017-04-25
10817740020420BIONIX RADIATION THERAPYBIONIX RADIATION THERAPY, LLCEMRT-87402017-04-25
10817740021045BIONIX RADIATION THERAPYBIONIX RADIATION THERAPY, LLCEMRT-83312017-10-10