FDA.reportPublic FDA data

Yxoss

Primary DI
04251880700009
Brand
Yxoss
Company
ReOss GmbH
Model
Yxoss CBR
Published
2020-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K192747000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192747000Yxoss CBR®Reoss GmbH2020-06-17JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251880700009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251880700009042518807000094251880700009

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial surgical meshAn implantable, non-bioabsorbable, woven/knitted porous material made of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE)] intended to temporarily provide stabilization and support to a bone graft in the alveolar ridges, maxilla, or mandible. It is typically placed between the bone graft and soft tissue during dental or maxillofacial reconstruction and augmentation surgical procedures.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
341422829
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809233620106ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620113ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620120ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620137ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620144ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620151ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620168ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620182ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620199ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620205ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620298ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620304ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620311ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620335ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620342ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620366ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620380ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620397ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620403ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620410ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620427ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620489ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620502ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620526ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620533ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620540ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620557ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620625ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620632ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620649ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11