FDA.report

CMF VISIONARE

Primary DI
00810004514799
Brand
CMF VISIONARE
Company
VISIONARE, LLC
Model
1.907.155
Catalog number
1.907.155
Device description
Regular Straight Sagittal Locking Miniplate, T1.0mm
Published
2019-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JEYPlate, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
JEYPlate, BoneDental2

Premarket Submissions

SubmissionSupplement
K180204000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810004514799PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810004514799008100045147998100045147990810004514799

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1 239-244-2973customerservice@visionare.us

Regulatory Flags

DUNS number
026544675
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810004514621CMF VISIONARE1.907.1381.907.1382019-02-20
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00888118149671LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149701LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
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00888118149725LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149732LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149749LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149756LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149763LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149770LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149787LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149794LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149800LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149817LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149824LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149831LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149848LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149855LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149879LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149886LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149893LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149909LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149916LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149923LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149930LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149947LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149954LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149961LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149978LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118149985LEVEL ONE CMF, STERILEKLS-Martin L.P.JEY2026-03-23
00888118153128LEVEL ONE NEURO, STERILEKLS-Martin L.P.JEY2026-03-23