FDA.reportPublic FDA data

MEDPOR

Primary DI
07613252085355
Brand
MEDPOR
Company
Stryker Leibinger GmbH & Co. KG
Model
88038
Catalog number
88038
Device description
Contoured Mandibular Angle - Right
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FWPPROSTHESIS, CHIN, INTERNAL

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K922489000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K922489000MEDPOR SURG IMPLANT MATERIAL:PREFOR CRAN/FAC IMPLAPorex Technologies Corp.1992-09-02FWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613252085355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613252085355076132520853557613252085355

GMDN Terms#

Term, Definition table
TermDefinition
Mandibular condyle prosthesisA sterile implantable device designed to replace the natural mandibular condylar head, providing an articulation with the mandibular fossa and a partial substitution of the temporomandibular joint articulation. It is typically made of a combination of a metal frame and plastic (e.g., polymethylmethacrylate) or a combination of metal and polymeric materials. The device is almost always used in combination with mandibular fossa components in total temporomandibular joint (TMJ) prostheses.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length59Millimeter
Width29Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316153956
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
07613327300086NA78-8002078-800202021-01-27
07613327300109NA78-8004078-800402021-01-27
07613327300123NA78-8003078-800302021-01-27
04546540730763NA78-1001078-100102015-07-03
04546540730787NA78-1003078-100302015-07-03
04546540730794NA78-1004078-100402015-07-03
04546540730800NA78-1010078-101002015-07-03
07613327004021NA78-1002078-100202015-07-03
07613327129236NA78-4001078-400102015-09-24
07613327129243NA78-4010078-401002015-09-24
07613327129250NA78-4004078-400402015-09-24
07613327129267NA78-5003078-500302015-09-24
07613327129274NA78-5004078-500402015-09-24
07613327129281NA78-5002078-500202015-09-24
07613327129298NA78-4003078-400302015-09-24
07613327129328NA78-5001078-500102015-09-24
07613327129335NA78-4002078-400202015-09-24
07613327300017NA78-7002078-700202017-02-21
07613327300031NA78-7004078-700402017-02-21
07613327300055NA78-7003078-700302017-02-21

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
00815285022766Su-Por Surgical ImplantPORIFEROUS, LLCFWP2020-03-25
00815285022773Su-Por Surgical ImplantPORIFEROUS, LLCFWP2020-03-25
00815285022780Su-Por Surgical ImplantPORIFEROUS, LLCFWP2020-03-25
00815285022797Su-Por Surgical ImplantPORIFEROUS, LLCFWP2020-03-25
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