FDA.reportPublic FDA data

ACR Bone Screw

Primary DI
08809233620403
Brand
ACR Bone Screw
Company
BioMaterials Korea, Inc.
Model
OSS-T2015
Published
2026-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K110926000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110926000BONE PLATE; BONE SCREWBiomaterials Korea, Inc.2011-12-08JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809233620403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809233620403088092336204038809233620403

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, cover a burr hole and/or position/stabilize a prosthesis. 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 packaged with the plate.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
689679066
Device count
1
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809233620106ACR Bone ScrewOSS-T15352026-05-11
08809233620113ACR Bone ScrewOSS-T15042026-05-11
08809233620120ACR Bone ScrewOSS-T15052026-05-11
08809233620137ACR Bone ScrewOSS-T15062026-05-11
08809233620144ACR Bone ScrewOSS-T15072026-05-11
08809233620151ACR Bone ScrewOSS-T15082026-05-11
08809233620168ACR Bone ScrewOSS-T15092026-05-11
08809233620182ACR Bone ScrewOSS-T15112026-05-11
08809233620199ACR Bone ScrewOSS-T15132026-05-11
08809233620205ACR Bone ScrewOSS-T15152026-05-11
08809233620298ACR Bone ScrewOSS-T20042026-05-11
08809233620304ACR Bone ScrewOSS-T20052026-05-11
08809233620311ACR Bone ScrewOSS-T20062026-05-11
08809233620335ACR Bone ScrewOSS-T20072026-05-11
08809233620342ACR Bone ScrewOSS-T20082026-05-11
08809233620366ACR Bone ScrewOSS-T20092026-05-11
08809233620380ACR Bone ScrewOSS-T20112026-05-11
08809233620397ACR Bone ScrewOSS-T20132026-05-11
08809233620410ACR Bone ScrewOSS-T20172026-05-11
08809233620427ACR Bone ScrewOSS-T20192026-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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