Cranial orthosis

Definition
A custom-made helmet-like device intended to be worn on the head of an infant with an abnormal head shape (e.g., due to plagiocephaly, brachycephaly, scaphocephaly), or after craniosynostosis repair surgery, to apply pressure to the cranium and improve cranial symmetry/shape during growth over a period of months. It is made of durable materials (e.g., plastic, solid foam) and is designed with patient-specific characteristics (e.g., size, shape) based on head measurements (e.g., clinical pictures, 3-D scans, casts). It is typically worn during daily activities and sleep. This is a single-patient device that can be reapplied during the treatment period (reusable) before being discarded.
GUDID devices
159
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00859065006041Hanger Cranial BandSymbiont Logistics, LLCF82102026-05-11
00860013898083TaleeINVENT MEDICAL USA LLCTalee w/G1-Bi-Valve Opening2026-04-28
00860013898090Talee PostOpINVENT MEDICAL USA LLCTalee PostOp w/G1-Bi-Valve Opening2026-04-28
00860015811103TaleeINVENT MEDICAL USA LLCTalee w/G2-Bi-Valve Opening2026-04-28
00860015811110Talee PostOpINVENT MEDICAL USA LLCTalee PostOp w/G2-Bi-Valve Opening2026-04-28
00860013026103Doc Band®Cranial Technologies, Inc.CRANIALHELMET2026-03-04
00860013026110Doc Band®Cranial Technologies, Inc.CRANIALHELMET3D2026-03-04
00860013898007TaleeINVENT MEDICAL USA LLCTalee w/One-Side Opening2025-05-12
00860013898014TaleeINVENT MEDICAL USA LLCTalee w/Bi-Valve Opening2025-05-12
00860013898021TaleeINVENT MEDICAL USA LLCTalee w/2in1/One-Side Opening2025-05-12
00860013898038TaleeINVENT MEDICAL USA LLCTalee w/2in1/Bi-Valve Opening2025-05-12
00860013898045Talee PostOpINVENT MEDICAL USA LLCTalee PostOp w/One-Side Opening2025-05-12
00860013898052Talee PostOpINVENT MEDICAL USA LLCTalee PostOp w/Bi-Valve Opening2025-05-12
00860013898069Talee PostOpINVENT MEDICAL USA LLCTalee PostOp w/2in1/One-Side Opening2025-05-12
00860013898076Talee PostOpINVENT MEDICAL USA LLCTalee PostOp w/2in1/Bi-Valve Opening2025-05-12
00859065006034Sprout3DSurestep, LLCA82102025-02-03
00859065006027Hanger Cranial Band 3DSymbiont Logistics, LLCA82102024-12-26
B15176210A0STARband® 3DORTHOMERICA PRODUCTS, INC.762.10A2024-10-17
B15176310A0STARband® 3DORTHOMERICA PRODUCTS, INC.763.10A2024-10-17
B15176410A0STARband® 3DORTHOMERICA PRODUCTS, INC.764.10A2024-10-17
B15176510A0STARband® 3DORTHOMERICA PRODUCTS, INC.765.10A2024-10-17
B15176610A0STARband® 3DORTHOMERICA PRODUCTS, INC.766.10A2024-10-17
00196852667895P-PODPPOD Orthotics Inc.DD-19302023-11-20
00860010708101Boston BandBoston Brace International, Inc.BB12023-09-13
B15170309A0STARband® PlusORTHOMERICA PRODUCTS, INC.703.09A2023-06-29
B15170309PA0STARband® PlusORTHOMERICA PRODUCTS, INC.703.09PA2023-06-29
B15170409A0STARband® PlusORTHOMERICA PRODUCTS, INC.704.09A2023-06-29
B15170409PA0STARband® PlusORTHOMERICA PRODUCTS, INC.704.09PA2023-06-29
B15170909A0STARband® PlusORTHOMERICA PRODUCTS, INC.709.09A2023-06-29
B15170909PA0STARband® PlusORTHOMERICA PRODUCTS, INC.709.09PA2023-06-29
B15170910A0STARband® 3DORTHOMERICA PRODUCTS, INC.709.10A2023-06-29
B15176009A0STARband® PlusORTHOMERICA PRODUCTS, INC.760.09A2023-06-29
B15176009PA0STARband® PlusORTHOMERICA PRODUCTS, INC.760.09PA2023-06-29
B15176109A0STARband® PlusORTHOMERICA PRODUCTS, INC.761.09A2023-06-29
B15176109PA0STARband® PlusORTHOMERICA PRODUCTS, INC.761.09PA2023-06-29
B15176209A0STARband® PlusORTHOMERICA PRODUCTS, INC.762.09A2023-06-29
B15176209PA0STARband® PlusORTHOMERICA PRODUCTS, INC.762.09PA2023-06-29
B15176309A0STARband® PlusORTHOMERICA PRODUCTS, INC.763.09A2023-06-29
B15176309PA0STARband® PlusORTHOMERICA PRODUCTS, INC.763.09PA2023-06-29
B15176409A0STARband® PlusORTHOMERICA PRODUCTS, INC.764.09A2023-06-29
B15176409PA0STARband® PlusORTHOMERICA PRODUCTS, INC.764.09PA2023-06-29
B15176509A0STARband® PlusORTHOMERICA PRODUCTS, INC.765.09A2023-06-29
B15176509PA0STARband® PlusORTHOMERICA PRODUCTS, INC.765.09PA2023-06-29
B15176601A0STARlight® Bi-ValveORTHOMERICA PRODUCTS, INC.766.01A2023-06-29
B15176601PA0STARlight® Bi-ValveORTHOMERICA PRODUCTS, INC.766.01PA2023-06-29
B15176603A0STARlight®ORTHOMERICA PRODUCTS, INC.766.03A2023-06-29
B15176603PA0STARlight®ORTHOMERICA PRODUCTS, INC.766.03PA2023-06-29
B15176606A0STARband® Bi-ValveORTHOMERICA PRODUCTS, INC.766.06A2023-06-29
B15176606PA0STARband® Bi-ValveORTHOMERICA PRODUCTS, INC.766.06PA2023-06-29
B15176607PA0STARlight® PROORTHOMERICA PRODUCTS, INC.766.07PA2023-06-29
B15176609A0STARband® PlusORTHOMERICA PRODUCTS, INC.766.09A2023-06-29
B15176609PA0STARband® PlusORTHOMERICA PRODUCTS, INC.766.09PA2023-06-29
B151766A0STARband®ORTHOMERICA PRODUCTS, INC.766A2023-06-29
B151766PA0STARband®ORTHOMERICA PRODUCTS, INC.766PA2023-06-29
04064409000012MyCRO BandOTTO BOCK HEALTHCARE24H1=12021-03-29
04064409000029MyCRO BandOTTO BOCK HEALTHCARE24H1=112021-03-29
04064409000036MyCRO BandOTTO BOCK HEALTHCARE24H1=122021-03-29
04064409000043MyCRO BandOTTO BOCK HEALTHCARE24H1=132021-03-29
04064409000050MyCRO BandOTTO BOCK HEALTHCARE24H1=2.52021-03-29
04064409000067MyCRO BandOTTO BOCK HEALTHCARE24H1=32021-03-29
04064409000074MyCRO BandOTTO BOCK HEALTHCARE24H1=52021-03-29
04064409000081MyCRO BandOTTO BOCK HEALTHCARE24H1=72021-03-29
04064409000098MyCRO BandOTTO BOCK HEALTHCARE24H1=82021-03-29
04064409000104MyCRO BandOTTO BOCK HEALTHCARE24H1=92021-03-29
B590507012000STARscannerVorum Research CorporationSeries B2021-03-02
B15170301A0STARlight® Bi-ValveORTHOMERICA PRODUCTS, INC.703.01A2016-08-18
B15170301PA0STARlight® Bi-ValveORTHOMERICA PRODUCTS, INC.703.01PA2016-08-22
B15170303A0STARlight®ORTHOMERICA PRODUCTS, INC.703.03A2016-08-22
B15170303PA0STARlight®ORTHOMERICA PRODUCTS, INC.703.03PA2016-08-22
B15170305A0Clarren HelmetORTHOMERICA PRODUCTS, INC.703.05A2016-08-22
B15170306A0STARband® Bi-ValveORTHOMERICA PRODUCTS, INC.703.06A2016-08-22
B15170306PA0STARband® Bi-ValveORTHOMERICA PRODUCTS, INC.703.06PA2016-08-22
B15170307PA0STARlight® PROORTHOMERICA PRODUCTS, INC.703.07PA2016-08-22
B151703A0STARband®ORTHOMERICA PRODUCTS, INC.703A2016-08-22
B151703PA0STARband®ORTHOMERICA PRODUCTS, INC.703PA2016-08-22
B15170401A0STARlight® Bi-ValveORTHOMERICA PRODUCTS, INC.704.01A2016-08-22
B15170401PA0STARlight® Bi-ValveORTHOMERICA PRODUCTS, INC.704.01PA2016-08-22
B15170403A0STARlight®ORTHOMERICA PRODUCTS, INC.704.03A2016-08-22
B15170403PA0STARlight®ORTHOMERICA PRODUCTS, INC.704.03PA2016-08-22
B15170405A0Clarren HelmetORTHOMERICA PRODUCTS, INC.704.05A2016-08-22