FDA.reportPublic FDA data

OmniPore Customized Surgical Implant

Primary DI
00855421005413
Brand
OmniPore Customized Surgical Implant
Company
MATRIX SURGICAL HOLDINGS, LLC
Model
OP89021
Device description
Customized Facial Implant
Published
2020-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial ReconstructionGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133046000OMNIPORE CUSTOMIZED SURGICAL IMPLANTSMatrix Surgical Holdings, LLC/Matrix Surgical USA2014-05-14KKY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855421005413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855421005413008554210054138554210054130855421005413

GMDN Terms#

Term, Definition table
TermDefinition
Polyethylene craniofacial tissue reconstructive materialA 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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
079634199
Device count
1
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852578008298Matrix Seiff Ptosis SlingMTX10042025-06-05
00855421005079OmniPore Surgical ImplantOP93122020-04-21
00855421005086OmniPore Surgical Implant OP95412020-04-23
00855421005093OmniPore Surgical Implant OP95422020-04-23
00855421005109OmniPore Surgical Implant OP95432020-04-23
00855421005116OmniPore Surgical Implant OP9544 2020-04-23
00852578008199OmniPore Surgical Implant OP63002023-12-20
00852578008205OmniPore Surgical Implant OP63012023-12-20
00852578008212OmniPore Surgical Implant OP63022023-12-20
00852578008229OmniPore Surgical Implant OP63032023-12-20
00852578008236OmniPore Surgical Implant OP83342023-08-07
00852578008243OmniPore Surgical Implant OP83352023-08-07
00852578008250OmniPore Surgical Implant OP83362023-08-07
00852578008267OmniPore Surgical Implant OP83372023-08-07
00852578008274OmniPore Surgical Implant OP83382023-08-07
00852578008281OmniPore Surgical Implant OP83392023-08-07
00855421005260OmniPore Surgical ImplantOP83282020-04-21
00855421005277OmniPore Surgical ImplantOP83292020-04-21
00855421005284OmniPore Surgical ImplantOP83302020-04-21
00855421005291OmniPore Surgical ImplantOP83312020-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810188324542HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2026-05-14
00810188323965HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2026-04-16
00810188323972HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2026-04-16
00810188322555HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2025-10-23
00810188322562HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2025-10-23
00810128537384HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2024-09-09
00810128531702HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-08-08
00810128531795HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-07-25
00810128530149HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-03-13
00810128530156HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-03-13
00810077249741HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-02-16
00810077249284HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-01-18
00810077248959HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-01-04
00810077247471HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-09-15
00810077247488HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-09-15
00810077247518HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-09-08
00810077245828HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-06-21
00810077245675HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-05-20
00810077244937HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-04-20
00810077243312HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-01-14
00810077242605HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-01-05
00810023928409HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2021-01-22
00810023927631HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2020-11-09
00810023925477HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2020-06-23
00810023924920HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2020-04-30
00810023923589HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2020-02-24
00810023920984HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2019-08-20
00810023920854HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2019-08-15
00810042038486HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2019-03-21
00810042036857HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2018-12-03