FDA.reportPublic FDA data

Polyethylene craniofacial tissue reconstructive material

Definition
A sterile implantable device intended to support, contour, and provide structure for the craniofacial anatomy (i.e., head and face including the chin, cheeks, nose, eye sockets and ears) during reconstructive and plastic surgery procedures. It is typically a high-density polyethylene (PE) material with an interconnecting pore structure that supports tissue ingrowth. The device is available in blocks, sheets, wedges and spheres that can be cut by the surgeon to meet the patient's specific needs. This is a single-use device.
GUDID devices
1,134
Last updated
2026-06-05 06:05:25

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00821925018426GYRUS ACMIGyrus ACMI, LLC1407912015-10-24
00821925020672GYRUS ACMIGyrus ACMI, LLC701405632015-10-24
00815285022766Su-Por Surgical ImplantPORIFEROUS, LLC44692020-03-25
00815285022773Su-Por Surgical ImplantPORIFEROUS, LLC44702020-03-25
00815285022780Su-Por Surgical ImplantPORIFEROUS, LLC44672020-03-25
00815285022797Su-Por Surgical ImplantPORIFEROUS, LLC44682020-03-25
00815285023220Su-Por Surgical ImplantsPORIFEROUS, LLC44952022-01-06
00815285024258SU-POR Surgical ImplantPORIFEROUS, LLC45092023-01-30
00815285025095SU-POR Surgical ImplantPORIFEROUS, LLC47162025-10-08
00815285025101SU-POR Surgical ImplantPORIFEROUS, LLC47172025-10-08
00815285025118SU-POR Surgical ImplantPORIFEROUS, LLC47202025-10-08
00815285025125SU-POR Surgical ImplantPORIFEROUS, LLC47212025-10-08
00855421005017OmniPore Surgical ImplantMATRIX SURGICAL HOLDINGS, LLCOP84382020-04-21
00855421005062OmniPore Surgical ImplantMATRIX SURGICAL HOLDINGS, LLCOP83122020-04-21
00855421005246OmniPore Surgical ImplantMATRIX SURGICAL HOLDINGS, LLCOP83202020-04-21
00855421005253OmniPore Surgical ImplantMATRIX SURGICAL HOLDINGS, LLCOP83212020-04-21
00855421005437OmniPore Customized Surgical ImplantMATRIX SURGICAL HOLDINGS, LLCOP890232020-05-28
00855421005444OmniPore Customized Surgical Implant MATRIX SURGICAL HOLDINGS, LLCOP890242020-05-28
00855421005451OmniPore Customized Surgical Implant MATRIX SURGICAL HOLDINGS, LLCOP890252020-05-28
00855421005468OmniPore Customized Surgical ImplantMATRIX SURGICAL HOLDINGS, LLCOP890262020-05-28
00855421005499OmniPore Surgical ImplantMATRIX SURGICAL HOLDINGS, LLCOP83222020-04-21
00855421005505OmniPore Surgical ImplantMATRIX SURGICAL HOLDINGS, LLCOP83132020-04-21
00855421005512OmniPore Surgical ImplantMATRIX SURGICAL HOLDINGS, LLCOP83142020-04-21
00855421005529OmniPore Surgical ImplantMATRIX SURGICAL HOLDINGS, LLCOP83152020-04-21
00855421005536OmniPore Surgical ImplantMATRIX SURGICAL HOLDINGS, LLCOP83162020-04-21
00855421005543OmniPore Surgical ImplantMATRIX SURGICAL HOLDINGS, LLCOP83172020-04-21
00855421005550OmniPore Surgical ImplantMATRIX SURGICAL HOLDINGS, LLCOP83182020-04-21
00855421005642OmniPore Surgical ImplantMATRIX SURGICAL HOLDINGS, LLCOP75412020-04-21
00855421005659OmniPore Surgical ImplantMATRIX SURGICAL HOLDINGS, LLCOP75422020-04-21
00855421005666OmniPore Surgical ImplantMATRIX SURGICAL HOLDINGS, LLCOP75432020-04-21
00855421005673OmniPore Surgical ImplantMATRIX SURGICAL HOLDINGS, LLCOP75442020-04-21
00855421005680OmniPore Surgical ImplantMATRIX SURGICAL HOLDINGS, LLCOP75452020-04-21
00855421005697OmniPore Surgical ImplantMATRIX SURGICAL HOLDINGS, LLCOP75462020-04-21
00855421005918OmniPore Surgical ImplantMATRIX SURGICAL HOLDINGS, LLCOP75502020-04-21
07613327300406MEDPORStryker Leibinger GmbH & Co. KG5444-2-4102023-01-09
07613327300413MEDPORStryker Leibinger GmbH & Co. KG5444-2-2102023-01-09
07613327300437MEDPORStryker Leibinger GmbH & Co. KG5444-1-6102023-01-09
07613327300444MEDPORStryker Leibinger GmbH & Co. KG5444-3-3102023-01-09
07613327300451MEDPORStryker Leibinger GmbH & Co. KG5444-2-1102023-01-09
07613327300475MEDPORStryker Leibinger GmbH & Co. KG5444-2-6102023-01-09
07613327300499MEDPORStryker Leibinger GmbH & Co. KG5444-1-5102023-01-09
07613327300505MEDPORStryker Leibinger GmbH & Co. KG5444-2-5102023-01-09
07613327300512MEDPORStryker Leibinger GmbH & Co. KG5444-3-5102023-01-09
07613327300529MEDPORStryker Leibinger GmbH & Co. KG5444-3-2102023-01-09
07613327300536MEDPORStryker Leibinger GmbH & Co. KG5444-3-4102023-02-13
07613327300550MEDPORStryker Leibinger GmbH & Co. KG5444-3-1102023-01-09
07613327300567MEDPORStryker Leibinger GmbH & Co. KG5444-2-3102023-01-09
10887587026015SynPORSynthes GmbH08.510.110S2015-09-14
10887587026039SynPORSynthes GmbH08.510.120S2015-09-14
10887587026053SynPORSynthes GmbH08.510.130S2015-09-14
10887587026077SynPORSynthes GmbH08.510.140S2015-09-14
10887587026114SynPORSynthes GmbH08.510.220S2015-09-14
10887587026145SynPORSynthes GmbH08.510.540S2015-09-14
10887587026152SynPORSynthes GmbH08.510.541S2015-09-14
10887587026176SynPORSynthes GmbH08.510.542S2015-09-14
10887587026183SynPORSynthes GmbH08.510.543S2015-09-14
10887587026190SynPORSynthes GmbH08.510.544S2015-09-14
10887587026206SynPORSynthes GmbH08.510.545S2015-09-14
10887587026220SynPORSynthes GmbH08.510.546S2015-09-14
10887587026237SynPORSynthes GmbH08.510.547S2015-09-14
10887587026244SynPORSynthes GmbH08.510.640S2015-09-14
10887587026251SynPORSynthes GmbH08.510.641S2015-09-14
10887587026275SynPORSynthes GmbH08.510.642S2015-09-14
10887587026329SynPORSynthes GmbH08.510.646S2015-09-14
10887587026343SynPORSynthes GmbH08.520.120S2015-09-14
10887587026367SynPORSynthes GmbH08.520.121S2015-09-14
10887587026374SynPORSynthes GmbH08.520.130S2015-09-14
10887587026381SynPORSynthes GmbH08.520.131S2015-09-14
10887587026404SynPORSynthes GmbH08.520.220S2015-09-14
10887587026428SynPORSynthes GmbH08.520.221S2015-09-14
10887587026442SynPORSynthes GmbH08.520.230S2015-09-14
10887587026466SynPORSynthes GmbH08.520.231S2015-09-14
20763000039909N/AMEDTRONIC XOMED, INC.14280052021-02-21
20763000039916N/AMEDTRONIC XOMED, INC.14280102021-02-21
UCR40640Biopor®CEREMED, INC.UCR-40642016-07-20
UCR60640Biopor®CEREMED, INC.UCR-6064 2016-07-20
UCR90640Biopor®CEREMED, INC.UCR-90642016-07-20
UCS40640Biopor®CEREMED, INC.UCS-40642016-07-20
UCS60640Biopor®CEREMED, INC.UCS-6064 2016-07-20
UCS90640Biopor®CEREMED, INC.UCS-90642016-07-20