FDA.reportPublic FDA data

CMF VISIONARE

Primary DI
00810004512405
Brand
CMF VISIONARE
Company
VISIONARE, LLC
Model
1.904.133
Catalog number
1.904.133
Device description
12 Hole Extra Long Straight Locking Miniplate, T1.0mm
Published
2019-02-15
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
K180204000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180204000CranioMaxillofacial Fixation (CMF) System - CMF VisionareVisionare, LLC2018-12-28JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810004512405PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810004512405008100045124058100045124050810004512405

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate, non-bioabsorbableA small, implantable sheet of firm material that is attached with screws to fractured craniofacial bone (including the maxilla and/or mandible), to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material cannot be chemically degraded or absorbed by natural body processes [includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre]. The device may also be used for craniofacial reconstructive procedures (e.g., to treat congenital malformations), endobrow fixation, or craniotomy flap fixation.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 239-244-2973customerservice@visionare.us

Regulatory Flags#

DUNS number
026544675
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
00810004510029CMF VISIONARE1.903.0021.903.0022019-02-13
00810004510036CMF VISIONARE1.903.0031.903.0032019-02-13
00810004510043CMF VISIONARE1.903.0041.903.0042019-02-13
00810004510050CMF VISIONARE1.903.0051.903.0052019-02-13
00810004510067CMF VISIONARE1.903.0061.903.0062019-02-13
00810004510074CMF VISIONARE1.903.0071.903.0072019-02-13
00810004510081CMF VISIONARE1.903.0081.903.0082019-02-13
00810004510098CMF VISIONARE1.903.0091.903.0092019-02-13
00810004510104CMF VISIONARE1.903.0101.903.0102019-02-13
00810004510111CMF VISIONARE1.903.0111.903.0112019-02-13
00810004510128CMF VISIONARE1.903.0121.903.0122019-02-13
00810004510135CMF VISIONARE1.903.0131.903.0132019-02-13
00810004510142CMF VISIONARE1.903.0141.903.0142019-02-13
00810004510159CMF VISIONARE1.903.0151.903.0152019-02-13
00810004510173CMF VISIONARE1.903.0171.903.0172019-02-13
00810004510180CMF VISIONARE1.903.0181.903.0182019-02-13
00810004510197CMF VISIONARE1.903.0191.903.0192019-02-13
00810004510203CMF VISIONARE1.903.0201.903.0202019-02-13
00810004510210CMF VISIONARE1.903.0211.903.0212019-02-13
00810004510227CMF VISIONARE1.903.0221.903.0222019-02-13

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