CurvaFix® IM Implant CRS-095-120-02

GUDID 10855068008010

The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fractures. It has a threaded, self-tapping distal end, and a proximal end feature for driving torque, and a lock feature that changes the IM Implant from a flexible to rigid state during implantation. The device is manufactured from Stainless Steel.

Curvafix Inc

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Primary Device ID10855068008010
NIH Device Record Key8d1d4c00-2df4-4fcb-b76c-141235773170
Commercial Distribution StatusIn Commercial Distribution
Brand NameCurvaFix® IM Implant
Version Model Number9.5 MM x 120 MM, Self Tapping
Catalog NumberCRS-095-120-02
Company DUNS039779098
Company NameCurvafix Inc
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

Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com
Phone425-276-8800
Emailsupport@curvafix.com

Device Dimensions

Outer Diameter9.5 Millimeter
Length120 Millimeter
Outer Diameter9.5 Millimeter
Length120 Millimeter
Outer Diameter9.5 Millimeter
Length120 Millimeter
Outer Diameter9.5 Millimeter
Length120 Millimeter
Outer Diameter9.5 Millimeter
Length120 Millimeter
Outer Diameter9.5 Millimeter
Length120 Millimeter
Outer Diameter9.5 Millimeter
Length120 Millimeter
Outer Diameter9.5 Millimeter
Length120 Millimeter
Outer Diameter9.5 Millimeter
Length120 Millimeter
Outer Diameter9.5 Millimeter
Length120 Millimeter
Outer Diameter9.5 Millimeter
Length120 Millimeter
Outer Diameter9.5 Millimeter
Length120 Millimeter
Outer Diameter9.5 Millimeter
Length120 Millimeter
Outer Diameter9.5 Millimeter
Length120 Millimeter
Outer Diameter9.5 Millimeter
Length120 Millimeter
Outer Diameter9.5 Millimeter
Length120 Millimeter
Outer Diameter9.5 Millimeter
Length120 Millimeter
Outer Diameter9.5 Millimeter
Length120 Millimeter
Outer Diameter9.5 Millimeter
Length120 Millimeter
Outer Diameter9.5 Millimeter
Length120 Millimeter
Outer Diameter9.5 Millimeter
Length120 Millimeter
Outer Diameter9.5 Millimeter
Length120 Millimeter
Outer Diameter9.5 Millimeter
Length120 Millimeter
Outer Diameter9.5 Millimeter
Length120 Millimeter
Outer Diameter9.5 Millimeter
Length120 Millimeter
Outer Diameter9.5 Millimeter
Length120 Millimeter
Outer Diameter9.5 Millimeter
Length120 Millimeter
Outer Diameter9.5 Millimeter
Length120 Millimeter
Outer Diameter9.5 Millimeter
Length120 Millimeter
Outer Diameter9.5 Millimeter
Length120 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110855068008010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-19
Device Publish Date2021-08-11

On-Brand Devices [CurvaFix® IM Implant]

10855068008102The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra
10855068008096The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra
10855068008089The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra
10855068008072The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra
10855068008065The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra
10855068008058The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra
10855068008041The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra
10855068008034The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra
10855068008027The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra
10855068008010The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra
10855068008003The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra
10855068008720The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra
10855068008713The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra
10855068008706The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra
10855068008690The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra
10855068008683The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra
10855068008676The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra
10855068008669The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra
10855068008652The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra
10855068008645The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra
10855068008638The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fra

Trademark Results [CurvaFix]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CURVAFIX
CURVAFIX
86297392 5503301 Live/Registered
CURVAFIX, INC.
2014-06-02

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