FDA.reportPublic FDA data

Custom-made cranial bone prosthesis

Definition
An implantable device intended to repair a defect of the cranium or mandible that is designed and constructed with specific characteristics (e.g., size, shape, material) as prescribed by a healthcare provider for a specified patient. It is typically manufactured from a three-dimensional (3-D) model based on computed tomography (CT) images and made of plastic [e.g., ultrahigh molecular weight polyethylene (UHMWPE), polyetheretherketone (PEEK)] and/or metal [e.g., titanium (Ti)]. The device may be used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease, or for cosmetic/aesthetic purposes.
GUDID devices
2,703
Last updated
2026-06-06 06:08:05

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810188324641HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK627330-A2026-05-28
00810188324658HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273332026-05-28
00810188324634HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK627331-A2026-05-27
00810023929918HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6240942021-05-28
00810023929970HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK624163-A2021-05-28
00810077242605HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6245342022-01-05
00810077243145HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6246952022-01-05
00810077243244HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6247362022-01-05
00810077243305HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6247352022-01-05
00810077243329HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK624725-A2022-01-05
00810077243343HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6247542022-01-05
00810077243398HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6247872022-01-06
00810077243442HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6247932022-01-06
00810077245521HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6251362022-05-27
00810077245781HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6251892022-05-27
00810077245798HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6251912022-05-27
00810077247471HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6251952022-09-15
00810077247488HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6251992022-09-15
00810077247501HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6254452022-09-15
00810077247556HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6254522022-09-15
00810077247594HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6254642022-09-16
00810077247600HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6254772022-09-16
00810077247617HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6254822022-09-16
00810077247624HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6254842022-09-16
00810077247631HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6254882022-09-15
00810077247785HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6254192022-11-01
00810077247921HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6255282022-11-01
00810077247945HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6255402022-11-01
00810077247983HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6255492022-11-01
00810077247990HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6254912022-11-01
00810077248072HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6255512022-10-27
00810077248102HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6255902022-11-01
00810077248157HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6255832022-11-01
00810077248195HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6256032022-11-01
00810077248478HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6256362022-12-13
00810077248485HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6256532022-12-13
00810077248553HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6256672022-12-19
00810077248607HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6256832022-12-09
00810077248638HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6256772022-12-13
00810077248669HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK625611-A2022-12-19
00810077248676HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK625623-A2022-12-08
00810077248683HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK625658-A2022-12-13
00810077248690HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6256742022-12-09
00810077248706HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6256942022-12-21
00810077248713HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6256932022-12-09
00810077248720HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257032022-12-09
00810077248737HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257042022-12-12
00810077248744HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257052022-12-19
00810077248751HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6256922022-12-14
00810077248775HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257082023-01-03
00810077248782HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257122022-12-19
00810077248799HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257202022-12-14
00810077248805HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK625573-A2022-12-19
00810077248812HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK625618-A2022-12-19
00810077248829HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257162023-01-16
00810077248836HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257132023-01-16
00810077248843HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257152022-12-19
00810077248850HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257182022-12-21
00810077248867HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257222022-12-19
00810077248874HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257252022-12-19
00810077248904HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257192022-12-21
00810077248911HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257302022-12-21
00810077248928HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257232022-12-21
00810077248942HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257352022-12-21
00810077248973HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257362023-01-09
00810077248980HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257062023-01-05
00810077248997HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257212022-12-22
00810077249000HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257462022-12-22
00810077249024HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257442023-01-12
00810077249031HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257452023-01-20
00810077249048HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK625714-A2023-01-09
00810077249055HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257322023-01-09
00810077249062HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257642023-01-09
00810077249086HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257332023-01-09
00810077249093HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257662023-01-12
00810077249109HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257672023-01-09
00810077249130HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257502023-01-26
00810077249154HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257622023-01-20
00810077249161HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257632023-01-20
00810077249178HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6257492023-01-26