Pro-fix™ Precision Fixation System

GUDID D765PFT350

1.5 mm x 3.0 mm self-drilling titanium alloy tenting screw

Osteogenics Biomedical Inc

Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable
Primary Device IDD765PFT350
NIH Device Record Keye7ed45d2-f036-4065-a2b1-1f707cc2e533
Commercial Distribution StatusIn Commercial Distribution
Brand NamePro-fix™ Precision Fixation System
Version Model NumberPFT3-5
Company DUNS123853058
Company NameOsteogenics Biomedical Inc
Device Count5
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter
Length3 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD765PFT350 [Unit of Use]
HIBCCD765PFT351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZLScrew, Fixation, Intraosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D765PFT350]

Moist Heat or Steam Sterilization


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Moist Heat or Steam Sterilization


[D765PFT350]

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[D765PFT350]

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[D765PFT350]

Moist Heat or Steam Sterilization


[D765PFT350]

Moist Heat or Steam Sterilization


[D765PFT350]

Moist Heat or Steam Sterilization


[D765PFT350]

Moist Heat or Steam Sterilization


[D765PFT350]

Moist Heat or Steam Sterilization


[D765PFT350]

Moist Heat or Steam Sterilization


[D765PFT350]

Moist Heat or Steam Sterilization


[D765PFT350]

Moist Heat or Steam Sterilization


[D765PFT350]

Moist Heat or Steam Sterilization


[D765PFT350]

Moist Heat or Steam Sterilization


[D765PFT350]

Moist Heat or Steam Sterilization


[D765PFT350]

Moist Heat or Steam Sterilization


[D765PFT350]

Moist Heat or Steam Sterilization


[D765PFT350]

Moist Heat or Steam Sterilization


[D765PFT350]

Moist Heat or Steam Sterilization


[D765PFT350]

Moist Heat or Steam Sterilization


[D765PFT350]

Moist Heat or Steam Sterilization


[D765PFT350]

Moist Heat or Steam Sterilization


[D765PFT350]

Moist Heat or Steam Sterilization


[D765PFT350]

Moist Heat or Steam Sterilization


[D765PFT350]

Moist Heat or Steam Sterilization


[D765PFT350]

Moist Heat or Steam Sterilization


[D765PFT350]

Moist Heat or Steam Sterilization


[D765PFT350]

Moist Heat or Steam Sterilization


[D765PFT350]

Moist Heat or Steam Sterilization


[D765PFT350]

Moist Heat or Steam Sterilization


[D765PFT350]

Moist Heat or Steam Sterilization


[D765PFT350]

Moist Heat or Steam Sterilization


[D765PFT350]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-21
Device Publish Date2021-01-13

On-Brand Devices [Pro-fix™ Precision Fixation System]

D765PFT5501.5 mm x 5.0 mm self-drilling titanium alloy tenting screw
D765PFT501.5 mm x 5.0 mm self-drilling titanium alloy tenting screw
D765PFT4501.5 mm x 4.0 mm self-drilling titanium alloy tenting screw
D765PFT401.5 mm x 4.0 mm self-drilling titanium alloy tenting screw
D765PFT3501.5 mm x 3.0 mm self-drilling titanium alloy tenting screw
D765PFT301.5 mm x 3.0 mm self-drilling titanium alloy tenting screw
D765PFMF5501.5 mm x 5.0 mm self-drilling titanium alloy membrane fixation screw
D765PFMF501.5 mm x 3.0 mm self-drilling titanium alloy membrane fixation screw
D765PFT8501.5 mm x 8.0 mm self-drilling fully threaded titanium alloy tenting screw
D765PFT801.5 mm x 8.0 mm self-drilling fully threaded titanium alloy tenting screw
D765PFT10501.5 mm x 10.0 mm self-drilling fully threaded titanium alloy tenting screw
D765PFT1001.5 mm x 10.0 mm self-drilling fully threaded titanium alloy tenting screw
D765PFB8501.5 mm x 8.0 mm self-tapping titanium alloy bone fixation screw
D765PFB801.5 mm x 8.0 mm self-tapping titanium alloy bone fixation screw
D765PFB14501.5 mm x 14.0 mm self-tapping titanium alloy bone fixation screw
D765PFB1401.5 mm x 14.0 mm self-tapping titanium alloy bone fixation screw
D765PFB12501.5 mm x 12.0 mm self-tapping titanium alloy bone fixation screw
D765PFB1201.5 mm x 12.0 mm self-tapping titanium alloy bone fixation screw
D765PFB10501.5 mm x 10.0 mm self-tapping titanium alloy bone fixation screw
D765PFB1001.5 mm x 10.0 mm self-tapping titanium alloy bone fixation screw
D765PFTK120Profix Tenting Kit
D765PFMK200Profix Membrane Fixation Kit
D765PFBK120Profix Bone Kit
D765PFT0Profix Tray

Trademark Results [Pro-fix]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PRO-FIX
PRO-FIX
90882126 not registered Live/Pending
Moen Incorporated
2021-08-13
PRO-FIX
PRO-FIX
87793840 5741053 Live/Registered
CobbleStone Investments LLC
2018-02-12
PRO-FIX
PRO-FIX
85066854 4060965 Live/Registered
Osteogenics Biomedical, Inc.
2010-06-18
PRO-FIX
PRO-FIX
85066853 4060964 Live/Registered
Osteogenics Biomedical, Inc.
2010-06-18
PRO-FIX
PRO-FIX
78757937 3246440 Live/Registered
Brampton Technology, LTD.
2005-11-21
PRO-FIX
PRO-FIX
73222484 1157160 Live/Registered
Kane Enterprises Inc.
1979-07-06

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