FDA.reportPublic FDA data

NA

Primary DI
07613327594775
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
92-12767
Catalog number
92-12767
Device description
L-plate, right, malleable
Published
2022-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JEYPLATE, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEYPlate, BoneDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327594775PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327594775076133275947757613327594775

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate, non-bioabsorbableA small implantable plate/set of plates designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible), to bridge and stabilize a fracture gap or craniotomy flap, and/or cover a burr hole; the material cannot be chemically degraded or absorbed by natural body processes. It is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover) and includes implant-grade metal; in addition to the plate(s) bone screws may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle100degree
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
316153956
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04546540717443ORTHOMAP6003-655-0006003-655-0002017-12-12
07613154272105HYDROSET3970033970032015-09-24
07613154272112HYDROSET3970053970052015-09-24
07613154272129HYDROSET3970103970102015-09-24
07613154272136HYDROSET3970153970152015-09-24
07613154274994HYDROSET79-4390379-439032015-09-24
07613154275007HYDROSET79-4390579-439052015-09-24
07613154275014HYDROSET79-4391079-439102015-09-24
07613154275021HYDROSET79-4391579-439152015-09-24
07613154804764HYDROSET3970233970232015-09-24
07613154804771HYDROSET3970213970212015-09-24
07613154804788HYDROSET7070017070012015-09-24
07613154888153HYDROSET3970273970272015-09-24
07613252510673CRANIALMAP6000-655-1006000-655-1002016-08-24
07613252510703CRANIALMAP6000-655-1506000-655-1502016-08-24
07613252510710CRANIALMAP6000-655-3006000-655-3002016-08-24
07613252510802CRANIALMAP6001-655-1506001-655-1502016-08-24
07613252510819CRANIALMAP6001-655-1006001-655-1002016-08-24
07613252510857CRANIALMAP6001-655-3006001-655-3002016-08-24
07613327004274CRANIALMAP6001-655-0006001-655-0002016-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118155498IPSKLS-Martin L.P.JEY2026-09-28
00888118155504IPSKLS-Martin L.P.JEY2026-09-28
00888118155511IPSKLS-Martin L.P.JEY2026-09-28
00888118155528IPSKLS-Martin L.P.JEY2026-09-28
00888118155535IPSKLS-Martin L.P.JEY2026-09-28
00888118155542IPSKLS-Martin L.P.JEY2026-09-28
00888118155559IPSKLS-Martin L.P.JEY2026-09-28
00888118155566IPSKLS-Martin L.P.JEY2026-09-28
07613327711578NAStryker Leibinger GmbH & Co. KGJEY2026-09-24
07613327711585NAStryker Leibinger GmbH & Co. KGJEY2026-09-24
07613327711592NAStryker Leibinger GmbH & Co. KGJEY2026-09-24
07613327711608NAStryker Leibinger GmbH & Co. KGJEY2026-09-24
04046826486228MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-07-29
04046826531478MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-07-29
04046826531485MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-07-29
04046826561741MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-07-29
04046826531454MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-07-28
00888118154620LEVEL ONE CMFKLS-Martin L.P.JEY2026-07-21
00888118154637LEVEL ONE CMFKLS-Martin L.P.JEY2026-07-21
07613327694482DELTAStryker Leibinger GmbH & Co. KGJEY2026-07-21
07613327694499DELTAStryker Leibinger GmbH & Co. KGJEY2026-07-21
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
07392532239045Symbios®Dentsply Implants Manufacturing GmbHJEY2024-01-30
07392532239052Symbios®Dentsply Implants Manufacturing GmbHJEY2024-01-30
07392532239038Symbios®Dentsply Implants Manufacturing GmbHJEY2024-01-29
EFRI325974002Symbios®Dentsply Implants Manufacturing GmbHJEY2020-11-03