Drill Wire Kit DWK-001

GUDID 10855068008126

A single use kit, composed of a sterile packaged Drill Wire and Exchange Tube, that is used during a surgical procedure for the placement of the CurvaFix IM Implant.

Curvafix Inc

Orthopaedic guidewire, single-use
Primary Device ID10855068008126
NIH Device Record Keyc9bebaf0-0459-40c3-8427-f21734417f4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameDrill Wire Kit
Version Model NumberDWK-001
Catalog NumberDWK-001
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 Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110855068008126 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-13
Device Publish Date2024-12-05

Devices Manufactured by Curvafix Inc

10855068008126 - Drill Wire Kit2024-12-13A single use kit, composed of a sterile packaged Drill Wire and Exchange Tube, that is used during a surgical procedure for the placement of the CurvaFix IM Implant.
10855068008126 - Drill Wire Kit2024-12-13 A single use kit, composed of a sterile packaged Drill Wire and Exchange Tube, that is used during a surgical procedure for the
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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.