Curvafix Inc

Address:1406 140th PL NE,Bellevue,WA,98007,US

Want to know more about this Organization? Request more information now!


Filters
Device Class
Product Code
Premarket Exempt
Clear
- Catalog Number : CCH-001

Device Description : A hand-held manual surgical instrument designed to strike the T-Handle to advanc A hand-held manual surgical instrument designed to strike the T-Handle to advance the CurvaFix Steerable Guide into the intramedullary space.

Device Class : 2

Duns Number: 039779098

Premarket Exempt : Yes

Product Code : HWC, HSB

Prescription Use : Yes

Device Count : 1

- Catalog Number : CFR-065

Device Description : A surgical drilling instrument (6.5mm diameter) intended to be connected to a st A surgical drilling instrument (6.5mm diameter) intended to be connected to a standard power tool, which is used to open and enlarge the medullary canal for the insertion of the CurvaFix IM Implant during a fracture fixation procedure. This device is cannulated so that it can be fed over a guiding wire that has been placed into the correct position inside the bone prior to operation of the drill.

Device Class : 2

Duns Number: 039779098

Premarket Exempt : Yes

Product Code : HWC, HSB

Prescription Use : Yes

Device Count : 1

- Catalog Number : CFR-070

Device Description : A surgical drilling instrument (7.0mm diameter) intended to be connected to a st A surgical drilling instrument (7.0mm diameter) intended to be connected to a standard power tool, which is used to open and enlarge the medullary canal for the insertion of the CurvaFix IM Implant during a fracture fixation procedure. This device is cannulated so that it can be fed over a guiding wire that has been placed into the correct position inside the bone prior to operation of the drill.

Device Class : 2

Duns Number: 039779098

Premarket Exempt : Yes

Product Code : HWC, HSB

Prescription Use : Yes

Device Count : 1

- Catalog Number : CFR-075

Device Description : A surgical drilling instrument (7.5mm diameter) intended to be connected to a st A surgical drilling instrument (7.5mm diameter) intended to be connected to a standard power tool, which is used to open and enlarge the medullary canal for the insertion of the CurvaFix IM Implant during a fracture fixation procedure. This device is cannulated so that it can be fed over a guiding wire that has been placed into the correct position inside the bone prior to operation of the drill.

Device Class : 2

Duns Number: 039779098

Premarket Exempt : Yes

Product Code : HWC, HSB

Prescription Use : Yes

Device Count : 1

- Catalog Number : CFR-080

Device Description : A surgical drilling instrument (8.0mm diameter) intended to be connected to a st A surgical drilling instrument (8.0mm diameter) intended to be connected to a standard power tool, which is used to open and enlarge the medullary canal for the insertion of the CurvaFix IM Implant during a fracture fixation procedure. This device is cannulated so that it can be fed over a guiding wire that has been placed into the correct position inside the bone prior to operation of the drill.

Device Class : 2

Duns Number: 039779098

Premarket Exempt : Yes

Product Code : HWC, HSB

Prescription Use : Yes

Device Count : 1

- Catalog Number : CFR-085

Device Description : A surgical drilling instrument (8.5mm diameter) intended to be connected to a st A surgical drilling instrument (8.5mm diameter) intended to be connected to a standard power tool, which is used to open and enlarge the medullary canal for the insertion of the CurvaFix IM Implant during a fracture fixation procedure. This device is cannulated so that it can be fed over a guiding wire that has been placed into the correct position inside the bone prior to operation of the drill.

Device Class : 2

Duns Number: 039779098

Premarket Exempt : Yes

Product Code : HWC, HSB

Prescription Use : Yes

Device Count : 1

- Catalog Number : CFR-090

Device Description : A surgical drilling instrument (9.0mm diameter) intended to be connected to a st A surgical drilling instrument (9.0mm diameter) intended to be connected to a standard power tool, which is used to open and enlarge the medullary canal for the insertion of the CurvaFix IM Implant during a fracture fixation procedure. This device is cannulated so that it can be fed over a guiding wire that has been placed into the correct position inside the bone prior to operation of the drill.

Device Class : 2

Duns Number: 039779098

Premarket Exempt : Yes

Product Code : HWC, HSB

Prescription Use : Yes

Device Count : 1

- Catalog Number : ISD-001

Device Description : Reusable surgical measurement instrument used when determining the size of the C Reusable surgical measurement instrument used when determining the size of the CurvaFix IM Implant to be used in a pelvic fixation procedure.

Device Class : 2

Duns Number: 039779098

Premarket Exempt : Yes

Product Code : HWC, HSB

Prescription Use : Yes

Device Count : 1

- Catalog Number : CIA-001

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. If needed, device can also be used to engage the implant during a removal procedure.

Device Class : 2

Duns Number: 039779098

Premarket Exempt : No

Product Code : HSB, HWC

Prescription Use : Yes

Device Count : 1

- Catalog Number : CIC-002

Device Description : Reusable, stainless steel instrument storage case that is used to contain the im Reusable, stainless steel instrument storage case that is used to contain the implant selection device during sterilization processing in preparation for pelvic fixation procedure.

Device Class : 2

Duns Number: 039779098

Premarket Exempt : Yes

Product Code : HWC, HSB

Prescription Use : Yes

Device Count : 1