FDA.reportPublic FDA data

CMF VISIONARE

Primary DI
10810004515786
Brand
CMF VISIONARE
Company
VISIONARE, LLC
Model
1.900.190
Catalog number
1.900.190
Device description
Emergency Self-Tapping Screw D2.3mm, 14mm
Published
2019-02-21
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
DZLScrew, Fixation, Intraosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZLScrew, Fixation, IntraosseousDental2

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
10810004515786PrimaryGS10
00810004515789Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081000451578610810004515786
00810004515789008100045157898100045157890810004515789

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head intended to be implanted or inserted short-term in craniofacial bone (including the maxilla and/or mandible) for fracture treatment or for the fixation of transplanted bone chips and/or small grafts (e.g., during an intraoral bone augmentation procedure). The device may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as surgical steel, titanium (Ti)]. This device is intended to be sterilized prior to use.

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
5
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
08800089458875Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458882Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458899Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458905Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458936Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458943Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458950Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458967Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458974Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458981Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089458998Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
08800089459001Leforte MMF SystemJeil Medical CorporationDZL2026-04-09
ESAM23053121STOMA®Storz am Mark GmbHDZL2025-04-30
ESAM23060091STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM23060111STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM23060131STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM23061091STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM23061111STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM23061131STOMA® micro-screwStorz am Mark GmbHDZL2024-01-12
ESAM21221001STOMA®Storz am Mark GmbHDZL2023-06-19
ESAM23053141STOMA®Storz am Mark GmbHDZL2023-06-19
ESAM23048001STOMA®Storz am Mark GmbHDZL2020-11-09
ESAM23049001STOMA®Storz am Mark GmbHDZL2020-08-27
08806390878029Jeil Bone Fixation SystemJeil Medical CorporationDZL2019-06-18
10810004515700CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515748CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515755CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515762CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515779CMF VISIONAREVISIONARE, LLCDZL2019-02-21
10810004515793CMF VISIONAREVISIONARE, LLCDZL2019-02-21