FDA.reportPublic FDA data

Cranial bone prosthesis, custom-made

Definition
A sterile 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
2,646
Last updated
2020-12-31 08:47:14

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810023928324HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6238292020-12-23
00810023928263HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6238272020-12-22
00810023928270HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6238312020-12-22
00810023928300HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6238322020-12-22
00810023928317HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6238252020-12-22
00810023927686HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK623708-A2020-12-21
00810023928188HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK623728-C2020-12-21
00810023928218HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6238202020-12-21
00810023928225HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6238112020-12-21
00810023927969HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237392020-12-18
00810023928157HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237962020-12-18
00810023928201HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6238132020-12-18
00810023928102HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237422020-12-15
00810023928133HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6238072020-12-15
00810023927716HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237412020-12-14
00810023927938HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237702020-12-14
00810023928164HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6238152020-12-14
00810023928171HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK623808-A2020-12-14
00810023928034HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK623743-A2020-12-11
00810023928041HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237842020-12-11
00810023928089HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6238042020-12-11
00810023928096HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6238102020-12-13
00810023927945HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237722020-12-09
00810023928072HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237712020-12-09
00810023927990HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237872020-12-08
00810023927976HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237812020-12-07
00810023927983HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237862020-12-07
00810023928010HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237782020-12-07
00810023927839HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237652020-12-04
00810023927891HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237582020-12-04
00810023928003HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237772020-12-04
00810023926313HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6234692020-12-01
00810023927785HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6236972020-12-02
00810023927815HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237622020-12-02
00810023927921HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237402020-12-02
00810023927952HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237762020-12-02
00810023927709HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237362020-11-30
00810023927860HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237642020-11-30
00810023927914HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237802020-11-30
00810023927884HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237682020-11-25
00810023927907HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237732020-11-25
00810023927471HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6236882020-11-24
00810023927600HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6236912020-11-24
00810023927662HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237042020-11-24
00810023927617HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237102020-11-20
00810023927822HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237632020-11-20
00810023927846HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237562020-11-20
00810023927853HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237662020-11-20
00810023927334HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6236732020-11-02
00810023927549HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237092020-11-02
00810023927273HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6236502020-10-30
00810023927372HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6236872020-10-30
00810023927426HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6236852020-10-30
00810023927518HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6237052020-10-30
00810023927402HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6236922020-10-28
00810023927419HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6236292020-10-28
00810023927433HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6236892020-10-28
00810023927464HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6236792020-10-28
00810023927457HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6236432020-10-27
00810023927389HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6236782020-10-26
00810023927396HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6236772020-10-26
00810023924470HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6230552020-10-23
00810023926955HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6234842020-10-23
00810023927013HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6235832020-10-23
00810023927341HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6236752020-10-23
00810023927358HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6236742020-10-23
00810023927259HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6235772020-10-20
00810023927181HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6236442020-10-19
00810023927228HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK623592-A2020-10-19
00810023927303HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6236632020-10-19
00810023927310HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6236142020-10-19
00810023927167HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6236372020-10-16
00810023927242HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6236472020-10-16
00810023927280HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6236452020-10-16
00810023927297HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6236592020-10-16
00810023927051HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6235632020-10-14
00810023927235HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6236322020-10-14
00810023927129HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6236262020-10-13
00810023927136HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6236382020-10-13
00810023925842HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.PK6233862020-10-12