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
2,778
Last updated
2026-10-29 05:55:23

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810188325839HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6274392026-10-20
00810188325914HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6274482026-10-20
00810188325938HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6274512026-10-20
00810188325945HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6274522026-10-19
00810188325907HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6274492026-10-16
00810188325884HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6274422026-10-14
00810188325891HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6274472026-10-14
00810188325853HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6274432026-10-13
00810188325563HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6274122026-10-12
00810188325815HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6274342026-10-12
00810188325860HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6274442026-10-12
00810188325877HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6274452026-10-12
00810188325846HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6274402026-10-09
00810188325785HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6274332026-10-08
00810188324801HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273482026-10-07
00810188325761HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK627048-A2026-10-07
00810188325617HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6274192026-10-06
00810188325778HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6274262026-10-06
00810188325716HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6274252026-10-05
00810188325792HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6274352026-10-05
00810188325808HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6274362026-10-05
00888118145819IPSKLS-Martin L.P.60-011-13-09-LP2026-10-01
00888118145826IPSKLS-Martin L.P.60-011-14-09-LP2026-10-01
00888118145833IPSKLS-Martin L.P.60-011-15-09-LP2026-10-01
00888118145840IPSKLS-Martin L.P.60-011-16-09-LP2026-10-01
00888118145857IPSKLS-Martin L.P.60-011-17-09-LP2026-10-01
00888118145864IPSKLS-Martin L.P.60-011-18-09-LP2026-10-01
00810188325709HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK627388-A2026-09-30
00810188325600HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6274162026-09-29
00810188325655HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6274182026-09-28
00810188325594HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK627393-A2026-09-25
00810188325679HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6274242026-09-24
00810188325624HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6274202026-09-21
00810188325631HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6274172026-09-21
00810188325457HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6274052026-09-04
00810188325464HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6274072026-09-04
00810188325303HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273922026-08-26
00810188325372HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273992026-08-26
00810188325389HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6274002026-08-26
00810188325327HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273942026-08-19
00810188325334HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273952026-08-19
00810188325297HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273912026-08-17
00810188325259HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273842026-08-07
00810188325266HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6273852026-08-07
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