FDA.reportPublic FDA data

NEOFACE

Primary DI
07898624864428
Brand
NEOFACE
Company
Neoortho Produtos Ortopédicos S/A.
Model
921.052
Device description
Y Long Microplate
Published
2015-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JEYPlate, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEYPlate, BoneDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102641000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102641000MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACENeoortho Produtos Ortopedicos S/A2010-12-20JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898624864428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898624864428078986248644287898624864428

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+554135351000sac@neoortho.com.br

Regulatory Flags#

DUNS number
914644351
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899893203253NEONAIL932.2002015-10-07
07899893203260NEONAIL932.2012015-10-07
07899893203277NEONAIL932.2022015-10-07
07899893203284NEONAIL932.2102015-10-07
07899893203291NEONAIL933.5002015-10-07
07899893203307NEONAIL934.9002015-10-07
07899893203314NEONAIL934.9012015-10-07
07899893203321NEONAIL934.9022015-10-07
07899893203338NEONAIL934.9032015-10-07
07899893203345NEONAIL934.9042015-10-07
07899893203352NEONAIL934.9052015-10-07
07899893203369NEONAIL934.9062015-10-07
07899893203376NEONAIL934.9072015-10-07
07898624867580NEOPLATE942.6002015-09-25
07898624867597NEOPLATE942.6012015-09-25
07898624867603NEOPLATE942.6022015-09-25
07898624867610NEOPLATE942.6032015-09-25
07898624867627NEOPLATE942.6042015-09-25
07898624867634NEOPLATE942.6052015-09-25
07898624867641NEOPLATE942.6062015-09-25

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