7.5MM Flexible Reamer CFR-075

GUDID 10855068008287

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.

Curvafix Inc

Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable Cannulated surgical drill bit, reusable
Primary Device ID10855068008287
NIH Device Record Keyad8b4783-273f-427a-b38e-352ab9f59b1a
Commercial Distribution StatusIn Commercial Distribution
Brand Name7.5MM Flexible Reamer
Version Model NumberCFR-075
Catalog NumberCFR-075
Company DUNS039779098
Company NameCurvafix Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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

Device Dimensions

Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter
Outer Diameter7.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110855068008287 [Primary]

FDA Product Code

HTOReamer
HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10855068008287]

Moist Heat or Steam Sterilization

[10855068008287]

Moist Heat or Steam Sterilization

[10855068008287]

Moist Heat or Steam Sterilization

[10855068008287]

Moist Heat or Steam Sterilization

[10855068008287]

Moist Heat or Steam Sterilization

[10855068008287]

Moist Heat or Steam Sterilization

[10855068008287]

Moist Heat or Steam Sterilization

[10855068008287]

Moist Heat or Steam Sterilization

[10855068008287]

Moist Heat or Steam Sterilization

[10855068008287]

Moist Heat or Steam Sterilization

[10855068008287]

Moist Heat or Steam Sterilization

[10855068008287]

Moist Heat or Steam Sterilization

[10855068008287]

Moist Heat or Steam Sterilization

[10855068008287]

Moist Heat or Steam Sterilization

[10855068008287]

Moist Heat or Steam Sterilization

[10855068008287]

Moist Heat or Steam Sterilization

[10855068008287]

Moist Heat or Steam Sterilization

[10855068008287]

Moist Heat or Steam Sterilization

[10855068008287]

Moist Heat or Steam Sterilization

[10855068008287]

Moist Heat or Steam Sterilization

[10855068008287]

Moist Heat or Steam Sterilization

[10855068008287]

Moist Heat or Steam Sterilization

[10855068008287]

Moist Heat or Steam Sterilization

[10855068008287]

Moist Heat or Steam Sterilization

[10855068008287]

Moist Heat or Steam Sterilization

[10855068008287]

Moist Heat or Steam Sterilization

Device Entry Metadata

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

Devices Manufactured by Curvafix Inc

10855068008744 - Removal Drill, 9.5mm2023-10-04 A cannulated drill bit that attaches to a surgical power tool. It is used over a guide pin to remove bone leading up to or cover
10855068008751 - Removal Drill, 13.0 mm2023-10-04 A cannulated drill bit that attaches to a surgical power tool. It is used over a guide pin to remove bone leading up to or cover
10855068008768 - Tissue Sleeve, Removal Tool2023-10-04 A hand-held stainless steel tube used during a CurvaFix Implant removal to maintain direct access to the Implant head and protec
10855068008782 - Pin Sleeve, Removal Tool2023-10-04 A hand-held stainless steel tube used during a CurvaFix Implant removal that fits inside the Tissue Sleeve and contains a conica
10855068008829 - Removal Tool Set2023-10-04 A custom engineered set of reusable surgical instruments, housed in a sterilizable storage container, that are used to remove a
10855068008836 - Sterilization Case, Removal Tool Set2023-10-04 A reusable instrument storage case that can house and retain the reusable instruments of the Removal Tool Set during sterilizati
10855068008843 - Removal Coring Tool, Proximal Head2023-10-04 A T-handled cutting instrument with a cannula used over a wire to manually remove bone in a cylindral shape around the proximal
10855068008850 - Removal Coring Tool, Distal Bead2023-10-04 A T-handled cutting instrument with a cannula used over a wire to manually remove bone in a cylindral shape around the Distal Be
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.