FDA.reportPublic FDA data

SU-POR Surgical Implant

Primary DI
00815285025125
Brand
SU-POR Surgical Implant
Company
PORIFEROUS, LLC
Model
4721
Catalog number
4721
Device description
Tah-Ear-I Rev. B - Large - Right
Published
2025-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K140437000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140437000SU-POR SURGICAL IMPLANTPoriferous, LLC2014-06-13KKY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815285025125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815285025125008152850251258152850251250815285025125

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.

Contacts#

Phone, Email table
PhoneEmail
770-683-3855info@poriferous.com

Regulatory Flags#

DUNS number
078388975
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00081528502436SU-POR Surgical Implant442144212024-10-16
00815285025071SU-POR Surgical Implant476747672026-01-13
00815285025088SU-POR Surgical Implant476847682026-01-13
00815285025132SU-POR Surgical Implant476547652026-01-13
00815285025149SU-POR Surgical Implant476647662026-01-13
00815285025156SU-POR Surgical Implant476947692026-01-13
00815285025163SU-POR Surgical Implant477047702026-01-13
00815285024777SU-POR Surgical Implant471847182024-12-11
00815285024784SU-POR Surgical Implant471947192024-12-11
00815285024791SU-POR Surgical Implant471647162024-12-11
00815285024807SU-POR Surgical Implant471747172024-12-11
00815285024814SU-POR Surgical Implant472047202024-12-11
00815285024821SU-POR Surgical Implant472147212024-12-11
00815285025095SU-POR Surgical Implant471647162025-10-08
00815285025101SU-POR Surgical Implant471747172025-10-08
00815285025118SU-POR Surgical Implant472047202025-10-08
00815285024869SU-POR Surgical Implant471847182025-09-17
00815285025064SU-POR Surgical Implant471947192025-09-17
00815285024883SU-POR Surgical Implant475347532025-07-17
00815285024890SU-POR Surgical Implant475445742025-07-17

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