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
2,735
Last updated
2026-08-12 10:12:52

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810188325044HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273702026-08-03
00810188325181HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273732026-08-03
00810188325204HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273802026-08-03
00810188325174HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273792026-07-31
00810188325129HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273742026-07-28
00810188325105HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273572026-07-27
00810188325099HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK627344-A2026-07-23
00810188325112HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273722026-07-23
00810188325068HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273712026-07-20
00810188325075HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK627343-B2026-07-20
00810188325082HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK627368-A2026-07-20
00810188325051HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273272026-07-17
00810188324955HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273592026-07-14
00810188325013HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273692026-07-14
00810188324795HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273472026-07-13
00810188324948HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273602026-07-13
00810188324986HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273652026-07-13
00810188324931HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273542026-07-10
00810188324979HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK627364-A2026-07-10
00810188324924HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273402026-07-09
00810188324818HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK627338-B2026-06-26
00810188324849HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273462026-06-26
00810188324856HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273492026-06-26
00810188324672HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273352026-06-22
00810188324702HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273362026-07-07
00810188324757HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273422026-06-22
00810188324788HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273452026-06-22
00810188324917HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273582026-07-06
00810188324177HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6272892026-06-09
00810188324719HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK627301-A2026-06-09
00810188324689HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK627326-A2026-06-03
00810188324665HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273342026-06-01
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