INTRAFIX 254683

GUDID 10886705013647

FEMORAL INTRAFIX, STANDARD Includes (1) 8mm Sheath and (1) 8mm Screw 8mm-8.5mm x 23mm

DEPUY MITEK, LLC

Orthopaedic bone screw (non-sliding)
Primary Device ID10886705013647
NIH Device Record Keyee83b2a5-4370-4aea-9b82-9532d1a64d04
Commercial Distribution StatusIn Commercial Distribution
Brand NameINTRAFIX
Version Model Number254683
Catalog Number254683
Company DUNS190572854
Company NameDEPUY MITEK, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
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Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
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Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110886705013647 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-11-02
Device Publish Date2015-09-01

On-Brand Devices [INTRAFIX]

10886705013524Femoral INTRAFIX Sheath Inserter 9mm - 10mm
10886705013517Femoral INTRAFIX Sheath Inserter 8mm - 8.5mm
10886705013500Femoral INTRAFIX Sheath Inserter 7mm - 7.5mm
10886705013494Femoral INTRAFIX Sheath Trial 9mm - 10mm
10886705013487Femoral INTRAFIX Sheath Trial 8mm - 8.5mm
10886705013470Femoral INTRAFIX Sheath Trial 7mm - 7.5mm
10886705013166INTRAFIX Family Tibial Sheath Inserter with Fixed Handle
10886705013159INTRAFIX Tibial Sheath Trial with Fixed Handle
10886705013142INTRAFIX Tibial Sheath Inserter with Fixed Handle
10886705005246Femoral INTRAFIX Sterilization Tray
10886705013661FEMORAL INTRAFIX, STANDARD Includes (1) 9mm Sheath and (1) 9mm Screw 9mm-10mm x 23mm
10886705013654FEMORAL INTRAFIX, HARD Includes (1) 9mm Sheath and (1) 8mm Screw 9mm-10mm x 23mm
10886705013647FEMORAL INTRAFIX, STANDARD Includes (1) 8mm Sheath and (1) 8mm Screw 8mm-8.5mm x 23mm
10886705013630FEMORAL INTRAFIX, HARD Includes (1) 8mm Sheath and (1) 7mm Screw 8mm-8.5mm x 23mm
10886705013623FEMORAL INTRAFIX, STANDARD Includes (1) 7mm Sheath and (1) 7mm Screw 7mm-7.5mm x 23mm
10886705013616FEMORAL INTRAFIX, HARD Includes (1) 7mm Sheath and (1) 6mm Screw 7mm-7.5mm x 23mm
10886705013692Femoral INTRAFIXSystem Positioner Replacement Screw
10886705013593Femoral INTRAFIX Graft Positioner

Trademark Results [INTRAFIX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INTRAFIX
INTRAFIX
76629628 3052822 Live/Registered
JOHNSON & JOHNSON
2005-01-27
INTRAFIX
INTRAFIX
74062180 not registered Dead/Abandoned
Orthofix S.R.L.
1990-05-24
INTRAFIX
INTRAFIX
72293928 0877779 Dead/Expired
INTRAVEND A.G.
1968-03-22

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