FDA.reportPublic FDA data

NA

Primary DI
07613327630664
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
92-04001
Catalog number
92-04001
Device description
Orbital floor plate slim long
Published
2023-11-29
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221855000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221855000Universal CMF SystemStryker Leibinger GmbH & Co KG2022-11-09JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327630664PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327630664076133276306647613327630664

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate, non-bioabsorbable, non-customizedA small, implantable, non-customized sheet of firm material 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. It is made of non-bioabsorbable materials (e.g., surgical steel, titanium alloy) and is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover). Instruments intended to facilitate implantation (e.g., driver), or plate fixation implants (i.e., bone screws), may be included with the plate.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
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
07613252286578FLUOROMAP6006-600-0006006-600-0002025-01-28
07613327542202N/A81-8007081-800702023-05-11
07613327542219N/A6003-700-3006003-700-3002023-05-11
07613327542363N/A6003-710-3006003-710-3002023-05-11
07613327542370N/A81-8007181-800712023-05-11
07613327542875N/A6007-700-3006007-700-3002023-05-11
07613327542998N/A81-8007281-800722023-05-11
04546540505712NA6004-650-0006004-650-0002016-08-24
04546540651600ORTHOMAP6005-660-0006005-660-0002016-08-24
04546540651624ORTHOMAP6005-661-0006005-661-0002016-08-24
07613154637164NA6004-650-3006004-650-3002016-08-24
07613252127413ORTHOMAP6005-660-3006005-660-3002016-08-24
07613252355717ORTHOMAP81-8005081-800502016-08-24
07613252433521ORTHOMAP6003-672-1006003-672-1002016-08-24
07613252433538ORTHOMAP6003-672-3006003-672-3002016-08-24
07613252448761ORTHOMAP6003-655-3006003-655-3002017-12-12
07613252448778ORTHOMAP6003-655-1006003-655-1002017-12-12
07613252449089ORTHOMAP81-8005581-800552017-12-12
04546540678683NGENIUS6003-034-0006003-034-0002016-08-24
04546540391735NA6007-425-0006007-425-0002017-12-12

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