Address:1406 140th PL NE,Bellevue,WA,98007,US
Device Description : A hand-held tubular surgical tool used during a CurvaFix procedure to facilitat A hand-held tubular surgical tool used during a CurvaFix procedure to facilitate the entry of a Guide Pin into the bone.
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 facilitate A hand-held stainless steel tube used during a CurvaFix procedure to facilitate the acceptance of a guidewire into the bone.
Device Class : 2
Duns Number: 039779098
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A T-handled instrument used to manually enlarge the diameter of the proximal po A T-handled instrument used to manually 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 : Reusable surgical instrument used to engage the proximal end of the flexible Cur Reusable surgical instrument used to engage the proximal end of the flexible CurvaFix® IM Implant in preparation for insertion into the intramedullary canal for implantation. Instrument can also be used to engage the implant during a removal procedure.
Device Class : 2
Duns Number: 039779098
Premarket Exempt : No
Prescription Use : Yes
Device Description : A smooth guidewire used to make the initial entry into the pelvic bone in the in A smooth guidewire 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 threaded guidewire used to make the initial entry into the pelvic bone in the A threaded guidewire 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 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 CurvaFix surgical procedure.
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 : A hand-held, stainless steel, tubular device placed into the proximal end of the A hand-held, stainless steel, tubular device placed into the proximal end of the CurvaFix Implant during removal to aid in proper reattachment of the Inserter/Extractor to the implant.
Device Class : 2
Duns Number: 039779098
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Stainless steel, ring-shaped device that may be added to the Inserter/Extractor. Stainless steel, ring-shaped device that may be added to the Inserter/Extractor. The addition of this device provides an additional level of robustness to the mechanism that attaches the inserter to the CurvaFix Implant
Device Class : 2
Duns Number: 039779098
Premarket Exempt : Yes
Prescription Use : Yes