Address:1406 140th PL NE,Bellevue,WA,98007,US
Device Description : An instrument that enables connection of the torque limiting handle to the Inser An instrument that enables connection of the torque limiting handle to the Inserter during implantation of the CurvaFix IM Implant.
Device Class : 2
Duns Number: 039779098
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A surgical instrument that allows a surgeon to insert the CurvaFix IM Implant in A surgical instrument that allows a surgeon to insert the CurvaFix IM Implant into the pelvis without exerting excess torque or force on the implant.
Device Class : 2
Duns Number: 039779098
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A custom engineered set consisting of reusable implant selection device, housed A custom engineered set consisting of reusable implant selection device, housed in a sterilizable storage container, that is used during a surgical procedure for the CurvaFix IM Implant.
Device Class : 2
Duns Number: 039779098
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Reusable instrument storage case that is used to contain the reusable instrument Reusable instrument storage case that is used to contain the reusable instruments during sterilization processing in preparation for pelvic fixation procedure.
Device Class : 2
Duns Number: 039779098
Premarket Exempt : No
Prescription Use : Yes
Device Description : Reusable surgical instrument used during pelvic fixation procedure to convert a Reusable surgical instrument used during pelvic fixation procedure to convert a flexible intramedullary implant to a rigid state in order to stabilize and repair a bone fracture.
Device Class : 2
Duns Number: 039779098
Premarket Exempt : No
Prescription Use : Yes
Device Description : A custom engineered set of reusable surgical instruments, housed in a sterilizab A custom engineered set of reusable surgical instruments, housed in a sterilizable storage container, that are used during a surgical procedure for the CurvaFix IM Implant.
Device Class : 2
Duns Number: 039779098
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Reusable surgical instrument used during pelvic fixation procedure to convert a Reusable surgical instrument used during pelvic fixation procedure to convert a flexible intramedullary implant to a rigid state in order to stabilize and repair a bone fracture.
Device Class : 2
Duns Number: 039779098
Premarket Exempt : No
Prescription Use : Yes
Device Description : A surgical instrument that allows a surgeon to insert the CurvaFix IM Implant in A surgical instrument that allows a surgeon to insert the CurvaFix IM Implant into the pelvis without exerting excess torque or force on the 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 procedure to maintain di A hand-held stainless steel tube used during a CurvaFix procedure to maintain direct access to the surgical site, protect the patient soft tissue, and facilitate the acceptance of other 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 Step Drill through it.
Device Class : 2
Duns Number: 039779098
Premarket Exempt : Yes
Prescription Use : Yes