FDA.reportPublic FDA data

NA

Primary DI
07613252578239
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
78-21020
Catalog number
78-21020
Device description
CUSTOMIZED MAND. RECON PLATE20 KIT, FULL
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
07613252578239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613252578239076132525782397613252578239

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate kit, non-bioabsorbableA collection of small sheets of firm material and bone screws, of various shapes/sizes, that are implanted onto 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 components are made of a material that is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Tools for implantation may be included. 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
Lot or batch
true
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