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
1,089
Last updated
2026-10-04 01:44:34

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00815285024180SU-POR Surgical ImplantPORIFEROUS, LLC46402022-08-01
00815285024197SU-POR Surgical ImplantPORIFEROUS, LLC46412022-08-01
00821925015357GYRUS ACMI, INCGyrus ACMI, LLC1408962015-10-24
00821925021457GYRUS ACMIGyrus ACMI, LLC709217852015-10-24
00821925022416Gyrus ACMIGyrus ACMI, LLC9111012015-10-24
00821925013964GYRUS ACMI, INCGyrus ACMI, LLC1400032015-10-24
00821925014039EVONOS GMBH & Co. KgGyrus ACMI, LLC1400532015-10-24
00821925014060EVONOS GMBH & Co. KgGyrus ACMI, LLC1400592015-10-24
00821925014190GYRUS ACMI, INCGyrus ACMI, LLC1401022015-10-24
00821925014497GYRUS ACMI, INCGyrus ACMI, LLC1401032015-10-24
00821925014534GYRUS ACMI, INCGyrus ACMI, LLC1400702015-10-24
00821925015500GYRUS ACMI, INCGyrus ACMI, LLC1401882015-10-24
00821925016088Gyrus ACMIGyrus ACMI, LLC1401672015-10-24
00821925016095GYRUS ACMI, INCGyrus ACMI, LLC1401682015-10-24
00821925016934GYRUS ACMI, INCGyrus ACMI, LLC1401492015-10-24
00821925017207GYRUS ACMI, INCGyrus ACMI, LLC1401082015-10-24
00821925017535GYRUS ACMI, INCGyrus ACMI, LLC1401162015-10-24
00821925017542GYRUS ACMI, INCGyrus ACMI, LLC1401202015-10-24
00821925017559GYRUS ACMI, INCGyrus ACMI, LLC1401212015-10-24
07613252457626MEDPORStryker Leibinger GmbH & Co. KG5444-0-1102015-09-24
07613252457633MEDPORStryker Leibinger GmbH & Co. KG5444-0-2102015-09-24
07613252457640MEDPORStryker Leibinger GmbH & Co. KG5444-0-3102015-09-24
07613252457657MEDPORStryker Leibinger GmbH & Co. KG5444-0-5102015-09-24
07613252457664MEDPORStryker Leibinger GmbH & Co. KG5444-0-4102015-09-24
07613252457671MEDPORStryker Leibinger GmbH & Co. KG5444-0-6102015-09-24
07613327300390MEDPORStryker Leibinger GmbH & Co. KG5444-1-1102017-02-21
07613327300420MEDPORStryker Leibinger GmbH & Co. KG5444-1-3102017-02-21
07613327300468MEDPORStryker Leibinger GmbH & Co. KG5444-1-2102017-02-21
07613327300482MEDPORStryker Leibinger GmbH & Co. KG5444-1-4102017-02-21
07613327480245MEDPORStryker Leibinger GmbH & Co. KG5444-0-7102019-09-20
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