FDA.reportPublic FDA data

NA

Primary DI
07613252599654
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
78-30028
Catalog number
78-30028
Device description
CUSTOMIZED MAND. RECON PLATE28, HEMI
Published
2015-07-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JEYPLATE, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEYPlate, BoneDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132519000
K193136000
K222650000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132519000STRYKER CUSTOMIZED MANDIBLE RECON PLATE KITStryker2013-12-06JEY
K193136000Stryker Customized Mandible Recon Plate KitStryker2020-03-26JEY
K222650000Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon PlateStryker Craniomaxillofacial (Cmf)2022-12-09JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613252599654PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613252599654076132525996547613252599654

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate, non-bioabsorbableA small, implantable sheet of firm material that is attached with screws to fractured craniofacial bone (including the maxilla and/or mandible), to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material cannot be chemically degraded or absorbed by natural body processes [includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre]. The device may also be used for craniofacial reconstructive procedures (e.g., to treat congenital malformations), endobrow fixation, or craniotomy flap fixation.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
316153956
Device count
1
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327480245MEDPOR5444-0-7105444-0-7102019-09-20
07613252457626MEDPOR5444-0-1105444-0-1102015-09-24
07613252457633MEDPOR5444-0-2105444-0-2102015-09-24
07613252457640MEDPOR5444-0-3105444-0-3102015-09-24
07613252457657MEDPOR5444-0-5105444-0-5102015-09-24
07613252457664MEDPOR5444-0-4105444-0-4102015-09-24
07613252457671MEDPOR5444-0-6105444-0-6102015-09-24
07613327300390MEDPOR5444-1-1105444-1-1102017-02-21
07613327300420MEDPOR5444-1-3105444-1-3102017-02-21
07613327300468MEDPOR5444-1-2105444-1-2102017-02-21
07613327300482MEDPOR5444-1-4105444-1-4102017-02-21
04546540001122COLORADOE1033E10332016-08-24
04546540001139COLORADOE1034E10342016-08-24
04546540001153COLORADOE1035E10352016-08-24
04546540001177COLORADOE1036E10362016-08-24
04546540001191COLORADOE1037E10372016-08-24
04546540001214COLORADOE1133E11332016-08-24
04546540001221COLORADOE1134E11342016-08-24
04546540001238COLORADOE1135E11352016-08-24
04546540001245COLORADOE1136E11362016-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046826346812MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826416676MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826542337MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826543655MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826552473MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
00888118126528LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2020-04-22
10888118113600LEVEL ONE CMFKLS-Martin L.P.JEY2017-10-20
10888118113617LEVEL ONE CMFKLS-Martin L.P.JEY2017-10-20
00888118001825LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118001870LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118002129LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118002136LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118003041LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118003058LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118003751LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118003775LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118003782LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118003799LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118003805LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118003935LEVEL ONE NEUROKLS-Martin L.P.JEY2016-03-24
00888118003942LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118003959LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118004840LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118005298LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118005304LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118005311LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118005441LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118005458LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118005571LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24
00888118005588LEVEL ONE CMFKLS-Martin L.P.JEY2016-03-24