FDA.reportPublic FDA data

METICULY Patient-specific titanium maxillofacial mesh implant

Primary DI
08859751212116
Brand
METICULY Patient-specific titanium maxillofacial mesh implant
Company
METICULY COMPANY LIMITED
Model
MF-211
Device description
METICULY Patient-specific titanium maxillofacial mesh implant : Orbital Mesh non-sterile
Published
2024-07-31
Public version status
Update
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
K232889000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232889000METICULY Patient-specific titanium maxillofacial mesh implantMeticuly Co., Ltd.2024-04-30JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18859751212113PackageGS11In Commercial Distribution
08859751212116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1885975121211318859751212113
08859751212116088597512121168859751212116

GMDN Terms#

Term, Definition table
TermDefinition
Orbital wall/rim prosthesisAn implantable ocular device used to reconstruct the orbital roof, floor, medial and/or lateral walls, and/or rim of the eye socket. It may be constructed of one of a variety of materials, or a combination, including stainless steel, titanium (Ti), titanium alloy, or flexible mesh alloplastics. It is an aspherical orbital volume replacement prosthesis that will typically have a spongy outer surface (e.g., reinforced with surgical mesh) designed to encourage tissue attachment and is intended to be used in conjunction with an artificial eye (not included).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
661695214
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08859751210556METICULY Patient-specific titanium mesh implantCP-0412026-03-05
08859751210563METICULY Patient-specific titanium mesh implantCP-0422026-03-05
08859751210570METICULY Patient-specific titanium mesh implantCP-0432026-03-05
08859751216206METICULY Patient-specific titanium mesh implantCP-3202026-03-05
08859751216312METICULY Patient-specific titanium mesh implantCP-3012026-03-05
08859751216329METICULY Patient-specific titanium mesh implantCP-3022026-03-05
08859751216336METICULY Patient-specific titanium mesh implantCP-3032026-03-05
08859751216343METICULY Patient-specific titanium mesh implantCP-3042026-03-05
08859751216411METICULY Patient-specific titanium mesh implantCP-3212026-03-05
08859751216428METICULY Patient-specific titanium mesh implantCP-3222026-03-05
08859751216435METICULY Patient-specific titanium mesh implantCP-3232026-03-05
08859751216442METICULY Patient-specific titanium mesh implantCP-3242026-03-05
18859751210553METICULY Patient-specific titanium mesh implantCP-0412026-03-05
18859751210560METICULY Patient-specific titanium mesh implantCP-0422026-03-05
18859751210577METICULY Patient-specific titanium mesh implantCP-0432026-03-05
08859751216008METICULY Patient-specific titanium mesh implantCP-3002026-03-05
18859751216203METICULY Patient-specific titanium mesh implantCP-3202026-03-05
18859751216319METICULY Patient-specific titanium mesh implantCP-3012026-03-05
18859751216326METICULY Patient-specific titanium mesh implantCP-3022026-03-05
18859751216333METICULY Patient-specific titanium mesh implantCP-3032026-03-05

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
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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
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08809233620342ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
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08809233620403ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620410ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
08809233620427ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
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08809233620502ACR Bone ScrewBioMaterials Korea, Inc.JEY2026-05-11
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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