FDA.reportPublic FDA data

Cervical spine immobilization system, single-use

Definition
An assembly of orthopaedic devices designed to immobilize the cervical spine (the bones in the neck) after an injury or surgery, to protect the bones from damaging movement during the healing processes. Commonly known as a Halo vest, it typically consists of a ring(s) around the head (the halo) which is attached to the skull with threaded bolts, a special padded vest/harness, four rods with locking mechanisms connecting the head ring to the vest, together with the appropriate instrumentation. This device may be made of ferrous or non-ferromagnetically active materials [to allow magnetic resonance imaging (MRI)], and is available in various sizes. This is a single-use device.
GUDID devices
2,222
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00650551044499PMT® CORPORATION HALOPMT CORPORATION1201-432018-01-11
00889813048047Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLC95035322022-05-02
10650551045820PMT® CORPORATION HALOPMT CORPORATION1201-852018-01-12
10650551093012PMT® CORPORATION HALOPMT CORPORATION1201-132018-01-09
10650551093029PMT® CORPORATION HALOPMT CORPORATION1201-142018-01-09
10650551093036PMT® CORPORATION HALOPMT CORPORATION1201-152018-01-09
10650551093043PMT® CORPORATION HALOPMT CORPORATION1206-202018-01-15
10650551093050PMT® CORPORATION HALOPMT CORPORATION1206-252018-01-15
10650551093067PMT® CORPORATION HALOPMT CORPORATION1206-322018-01-15
10650551093074PMT® CORPORATION HALOPMT CORPORATION1206-332018-01-15
10650551093081PMT® CORPORATION HALOPMT CORPORATION1201-18L2018-01-10
10650551093098PMT® CORPORATION HALOPMT CORPORATION1201-18M2018-01-10
10650551093104PMT® CORPORATION HALOPMT CORPORATION1201-18S2018-01-10
10650551093111PMT® CORPORATION HALOPMT CORPORATION1201-18X2018-01-10
10650551093128PMT® CORPORATION HALOPMT CORPORATION1201-192018-01-10
10650551093296PMT® CORPORATION HALOPMT CORPORATION1201-392018-01-11
10650551093302PMT® CORPORATION HALOPMT CORPORATION1201-452018-01-11
10650551093319PMT® CORPORATION HALOPMT CORPORATION1201-832018-01-11
10650551093609PMT® CORPORATION HALOPMT CORPORATION1201-322018-01-11
10650551093845PMT® CORPORATION HALOPMT CORPORATION1201-842018-01-12
10650551093920PMT® CORPORATION HALOPMT CORPORATION1201-512018-01-11
10650551094248PMT® CORPORATION HALOPMT CORPORATION1208-32018-01-15
10650551094255PMT® CORPORATION HALOPMT CORPORATION1210-62018-01-15
10705034243719BREMERDEPUY SPINE, LLCAC0072015-09-24
10705034245089BREMERDEPUY SPINE, LLCHT003P2015-09-24
10705034245096BREMERDEPUY SPINE, LLCHT003S2015-09-24
10705034341736BREMERDEPUY SPINE, LLCAC0142015-09-24
10705034341743BREMERDEPUY SPINE, LLCAC0252015-09-24
10705034341750BREMERDEPUY SPINE, LLCAC0502015-09-24
10705034341880BREMER 3D HALO CROWNDEPUY SPINE, LLC2923010012015-09-24
10705034341897BREMERDEPUY SPINE, LLCAC0182015-09-24
10705034341903BREMER HIFIXDEPUY SPINE, LLCAC0202015-09-24
10705034341910BREMERDEPUY SPINE, LLCHT0212015-09-24
10705034341927BREMERDEPUY SPINE, LLCHT0222015-09-24
10705034341934BREMER HALO CROWNDEPUY SPINE, LLCHT0352015-09-24
10705034341941BREMER HIFIXDEPUY SPINE, LLCHT035HI2015-09-24
10705034341958BREMER HALO CROWNDEPUY SPINE, LLCHT0362015-09-24
10705034341965BREMER HIFIXDEPUY SPINE, LLCHT036HI2015-09-24
10705034341972BREMERDEPUY SPINE, LLCPT0212015-09-24
10705034341989BREMERDEPUY SPINE, LLCPT0222015-09-24
00650551003861HALO TRAUMA KITPMT CORPORATION1211-6SS12025-03-10
00650551004417HALO TRAUMA KITPMT CORPORATION1201-3B22025-03-10
00650551004424HALO RINGPMT CORPORATION1201-1ME2025-03-10
00650551004790HALO RINGPMT CORPORATION1201-1LE2025-03-10
00650551042006HALO RINGPMT CORPORATION1201-1B2025-03-10
00650551042556HALO VEST LINERPMT CORPORATION1203-08D2025-03-10
00650551042563HALO VEST LINERPMT CORPORATION1203-08E2025-03-10
00650551042570HALO VEST LINERPMT CORPORATION1203-08F2025-03-10
00650551042587HALO VEST LINERPMT CORPORATION1203-08G2025-03-10
00650551042594HALO VEST LINERPMT CORPORATION1203-08H2025-03-10
00650551042600HALO VEST LINERPMT CORPORATION1203-08J2025-03-10
00650551042617HALO VEST LINERPMT CORPORATION1203-08L2025-03-10
00650551042624HALO VEST LINERPMT CORPORATION1203-08M2025-03-10
00650551042631HALO VEST LINERPMT CORPORATION1203-08S2025-03-10
00650551042648HALO VEST LINERPMT CORPORATION1203-08X2025-03-10
00650551042655HALO VEST LINERPMT CORPORATION1203-08Z2025-03-10
00650551042792HALO VEST LINERPMT CORPORATION1203-10D2025-03-10
00650551042808HALO VEST LINERPMT CORPORATION1203-10E2025-03-10
00650551042815HALO VEST LINERPMT CORPORATION1203-10F2025-03-10
00650551042822HALO VEST LINERPMT CORPORATION1203-10G2025-03-10
00650551042839HALO VEST LINERPMT CORPORATION1203-10H2025-03-10
00650551042846HALO VEST LINERPMT CORPORATION1203-10J2025-03-10
00650551042853HALO VEST LINERPMT CORPORATION1203-10L2025-03-10
00650551042860HALO VEST LINERPMT CORPORATION1203-10M2025-03-10
00650551042877HALO VEST LINERPMT CORPORATION1203-10S2025-03-10
00650551042884HALO VEST LINERPMT CORPORATION1203-10X2025-03-10
00650551042891HALO VEST LINERPMT CORPORATION1203-10Z2025-03-10
00650551045052HALO RINGPMT CORPORATION1208-1A2025-03-10
00650551045069HALO RINGPMT CORPORATION1208-1B2025-03-10
00650551093923HALO SYSTEM COMPONENTPMT CORPORATION1201-532025-03-10
00650551096252HALO RINGPMT CORPORATION1211-1SS2025-03-10
00650551098393HALO SYSTEM COMPONENTPMT CORPORATION1201-372025-03-10
00650551106548HALO RINGPMT CORPORATION1211-1AS2025-03-10
00650551106555HALO RINGPMT CORPORATION1211-1BS2025-03-10
00650551106562HALO RINGPMT CORPORATION1211-1LS2025-03-10
00650551106579HALO RINGPMT CORPORATION1211-1XS2025-03-10
00650551106586HALO RINGPMT CORPORATION1211-1MS2025-03-10
00650551106593HALO TRAUMA KITPMT CORPORATION1211-3MS12025-03-10
00650551117063HALO SYSTEM COMPONENTPMT CORPORATION1208-832025-03-10
00889813048023Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLC95035322022-05-02