FDA.reportPublic FDA data

CMF VISIONARE

Primary DI
00810004514928
Brand
CMF VISIONARE
Company
VISIONARE, LLC
Model
1.908.002
Catalog number
1.908.002
Device description
Blocking Screw D2.0, 6mm
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

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
00810004514928PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810004514928008100045149288100045149280810004514928

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
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800000987293Bone Screw, Bone TackOsstem Implant Co., Ltd.DZL2026-03-09
08800000987309Bone Screw, Bone TackOsstem Implant Co., Ltd.DZL2026-03-09
08800000987316Bone Screw, Bone TackOsstem Implant Co., Ltd.DZL2026-03-09
08800000987323Bone Screw, Bone TackOsstem Implant Co., Ltd.DZL2026-03-09
08800000987330Bone Screw, Bone TackOsstem Implant Co., Ltd.DZL2026-03-09
08800000987347Bone Screw, Bone TackOsstem Implant Co., Ltd.DZL2026-03-09
08800000987354Bone Screw, Bone TackOsstem Implant Co., Ltd.DZL2026-03-09
08800000987361Bone Screw, Bone TackOsstem Implant Co., Ltd.DZL2026-03-09
08800040644095Bone ScrewOsstem Implant Co., Ltd.DZL2026-03-09
08800040644118Bone ScrewOsstem Implant Co., Ltd.DZL2026-03-09
08800040644132Bone ScrewOsstem Implant Co., Ltd.DZL2026-03-09
08800040654599Bone Screw, Bone TackOsstem Implant Co., Ltd.DZL2026-03-09
08800040655848OssBuilder SystemOsstem Implant Co., Ltd.DZL2026-03-09
08800040655862OssBuilder SystemOsstem Implant Co., Ltd.DZL2026-03-09
08800040655886OssBuilder SystemOsstem Implant Co., Ltd.DZL2026-03-09
08800040655909OssBuilder SystemOsstem Implant Co., Ltd.DZL2026-03-09
ESAM23053120STOMA®Storz am Mark GmbHDZL2025-04-30
D765PFTK100Pro-fix™ Precision Fixation SystemOsteogenics Biomedical IncDZL2025-03-31
00888118142894LEVEL ONE CMF, STERILEKLS-Martin L.P.DZL2025-01-23
00888118142900LEVEL ONE CMF, STERILEKLS-Martin L.P.DZL2025-01-23
00888118145222LEVEL ONE CMF, STERILEKLS-Martin L.P.DZL2024-12-23
00888118145239LEVEL ONE CMF, STERILEKLS-Martin L.P.DZL2024-12-23
00888118145246LEVEL ONE CMF, STERILEKLS-Martin L.P.DZL2024-12-23
00888118145253LEVEL ONE CMF, STERILEKLS-Martin L.P.DZL2024-12-23
00888118145260LEVEL ONE CMF, STERILEKLS-Martin L.P.DZL2024-12-23
00888118145277LEVEL ONE CMF, STERILEKLS-Martin L.P.DZL2024-12-23
08056992093010MCBio Supertack Tack 3mm - N.5MC BIO SRLDZL2024-12-17
08056992093027MCBio Supertack Tack 3mm - N.10MC BIO SRLDZL2024-12-17
08056992093034MCBio Supertack Tack 4mm - N.5MC BIO SRLDZL2024-12-17
08056992093041MCBio Supertack Tack 5mm - N.5MC BIO SRLDZL2024-12-17