FDA.reportPublic FDA data

Su-Por Surgical Implant

Primary DI
00815285022766
Brand
Su-Por Surgical Implant
Company
PORIFEROUS, LLC
Model
4469
Catalog number
4469
Device description
3D Pterional Plate - Left 48mm x 44mm x 6mm
Published
2020-03-25
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
FWPProsthesis, Chin, Internal
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWPProsthesis, Chin, InternalGeneral, Plastic Surgery2
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
00815285022766PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815285022766008152850227668152850227660815285022766

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
770-683-3855devina@poriferous.com

Regulatory Flags#

DUNS number
078388975
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
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
00815285025125SU-POR Surgical Implant472147212025-10-08
00815285024869SU-POR Surgical Implant471847182025-09-17
00815285025064SU-POR Surgical Implant471947192025-09-17
00815285024883SU-POR Surgical Implant475347532025-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327300536MEDPORStryker Leibinger GmbH & Co. KGFWP2023-02-13
07613327300406MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300413MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300437MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300444MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300451MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300475MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300499MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300505MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300512MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300529MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300550MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
07613327300567MEDPORStryker Leibinger GmbH & Co. KGFWP2023-01-09
00810023923589HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2020-02-24
00810023920984HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2019-08-20
00810023920854HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2019-08-15
M724VMA11LNS1Vertical Mandibular Angle™IMPLANTECH ASSOCIATES, INC.FWP2019-05-15
M724VMA11RNS1Vertical Mandibular Angle™IMPLANTECH ASSOCIATES, INC.FWP2019-05-15
M724VMA13LNS1Vertical Mandibular Angle™IMPLANTECH ASSOCIATES, INC.FWP2019-05-15
M724VMA13RNS1Vertical Mandibular Angle™IMPLANTECH ASSOCIATES, INC.FWP2019-05-15
M724VMA7LNS1Vertical Mandibular Angle™IMPLANTECH ASSOCIATES, INC.FWP2019-05-15
M724VMA7RNS1Vertical Mandibular Angle™IMPLANTECH ASSOCIATES, INC.FWP2019-05-15
M724ACSIZNS1Anatomical Chin SizersIMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724CEACSIZNS1Conform™ Extended AnatomicalIMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724CSCSIZNS1Curvilinear Silicone Chin SizersIMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724EACSIZNS1Extended Anatomical Chin SizersIMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724FMGVSIZNS1Flowers Mandibular Glove® Sizers IMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724MPJSIZNS1Mandibular Pre Jowl® ImplantIMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724TEACSIZNS1Terino Extended Anatomical™IMPLANTECH ASSOCIATES, INC.FWP2017-10-17
M724TMALSIZNS1Lateral Mandibular Angle™ SizersIMPLANTECH ASSOCIATES, INC.FWP2017-10-17