Address:1406 140th PL NE,Bellevue,WA,98007,US
Device Description : The CurvaFix® IM Implant is an implantable intramedullary device for the fixatio 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.
Device Class : 2
Duns Number: 039779098
Premarket Exempt : No
Prescription Use : Yes
Device Description : A single use kit, composed of a sterile packaged Steerable Guide, Driving Guidew A single use kit, composed of a sterile packaged Steerable Guide, Driving Guidewire and Exchange Tube, that is used during a surgical procedure for the placement of the CurvaFix IM Implant.
Device Class : 2
Duns Number: 039779098
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A wire used to make the initial entry into the pelvic bone in the intended locat A wire used to make the initial entry into the pelvic bone in the intended location and angle for the CurvaFix Implant.
Device Class : 2
Duns Number: 039779098
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A hand-held stainless steel tube used during a CurvaFix Implant implantation pro A hand-held stainless steel tube used during a CurvaFix Implant implantation procedure to maintain direct access to the surgical site, protect the patient soft tissue, and facilitate the acceptance of orthopaedic instrumentation into the surgical site.
Device Class : 2
Duns Number: 039779098
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A hand-held tubular surgical device designed to be used during an CurvaFix Impla A hand-held tubular surgical device designed to be used during an CurvaFix Implant implantation procedure to facilitate the acceptance of a Guide Pin through it.
Device Class : 2
Duns Number: 039779098
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A hand-held tubular surgical device designed to be used during an CurvaFix Impla A hand-held tubular surgical device designed to be used during an CurvaFix Implant implantation procedure to facilitate the acceptance of a Step Drill through it.
Device Class : 2
Duns Number: 039779098
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A cannulated drill bit that attaches to a surgical power tool. It is used over a A cannulated drill bit that attaches to a surgical power tool. It is used over a guide pin to make the initial entry into the pelvic bone.
Device Class : 2
Duns Number: 039779098
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A manual rotary tool used to enlarge the diameter of the proximal portion of bon A manual rotary tool used to enlarge the diameter of the proximal portion of bone canal in preparation for insertion of the CurvaFix Implant.
Device Class : 2
Duns Number: 039779098
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A hand-held tubular surgical device designed to be used during an CurvaFix Impla A hand-held tubular surgical device designed to be used during an CurvaFix Implant implantation procedure to facilitate the acceptance of a Steerable Guide through it.
Device Class : 2
Duns Number: 039779098
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A hand-held manual surgical instrument designed to drive the CurvaFix Steerable A hand-held manual surgical instrument designed to drive the CurvaFix Steerable Guide into the intramedullary space.
Device Class : 2
Duns Number: 039779098
Premarket Exempt : Yes
Prescription Use : Yes