Cannulated Alignment Tube CAT-001

GUDID 10855068008584

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.

Curvafix Inc

Orthopaedic instrument extractor Orthopaedic instrument extractor Orthopaedic instrument extractor Orthopaedic instrument extractor Orthopaedic instrument extractor Orthopaedic instrument extractor Orthopaedic instrument extractor Orthopaedic instrument extractor Orthopaedic instrument extractor Orthopaedic instrument extractor Orthopaedic instrument extractor Orthopaedic instrument extractor Orthopaedic instrument extractor Orthopaedic instrument extractor Orthopaedic instrument extractor Orthopaedic instrument extractor Orthopaedic instrument extractor Orthopaedic instrument extractor Orthopaedic instrument extractor Orthopaedic instrument extractor Orthopaedic instrument extractor Orthopaedic instrument extractor Orthopaedic instrument extractor Orthopaedic instrument extractor Orthopaedic instrument extractor
Primary Device ID10855068008584
NIH Device Record Key8c620057-d4ea-415f-9162-0ec372e4e395
Commercial Distribution StatusIn Commercial Distribution
Brand NameCannulated Alignment Tube
Version Model NumberCAT-001
Catalog NumberCAT-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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS110855068008584 [Primary]

FDA Product Code

HSBRod, Fixation, Intramedullary And Accessories
LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10855068008584]

Moist Heat or Steam Sterilization


[10855068008584]

Moist Heat or Steam Sterilization


[10855068008584]

Moist Heat or Steam Sterilization


[10855068008584]

Moist Heat or Steam Sterilization


[10855068008584]

Moist Heat or Steam Sterilization


[10855068008584]

Moist Heat or Steam Sterilization


[10855068008584]

Moist Heat or Steam Sterilization


[10855068008584]

Moist Heat or Steam Sterilization


[10855068008584]

Moist Heat or Steam Sterilization


[10855068008584]

Moist Heat or Steam Sterilization


[10855068008584]

Moist Heat or Steam Sterilization


[10855068008584]

Moist Heat or Steam Sterilization


[10855068008584]

Moist Heat or Steam Sterilization


[10855068008584]

Moist Heat or Steam Sterilization


[10855068008584]

Moist Heat or Steam Sterilization


[10855068008584]

Moist Heat or Steam Sterilization


[10855068008584]

Moist Heat or Steam Sterilization


[10855068008584]

Moist Heat or Steam Sterilization


[10855068008584]

Moist Heat or Steam Sterilization


[10855068008584]

Moist Heat or Steam Sterilization


[10855068008584]

Moist Heat or Steam Sterilization


[10855068008584]

Moist Heat or Steam Sterilization


[10855068008584]

Moist Heat or Steam Sterilization


[10855068008584]

Moist Heat or Steam Sterilization


[10855068008584]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-28
Device Publish Date2022-06-20

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.