NexFix™ NCP System

GUDID 00846832006984

TORNIER, INC.

Orthopaedic bone pin, non-bioabsorbable
Primary Device ID00846832006984
NIH Device Record Keyab0e7945-05d5-46d9-9e9f-c5ff6d8e761e
Commercial Distribution StatusIn Commercial Distribution
Brand NameNexFix™ NCP System
Version Model NumberNCP-N2014
Company DUNS968990812
Company NameTORNIER, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com
Phone+1(888)494-7950
Emailcustomerservice@tornier.com

Device Dimensions

Length14 Millimeter
Length14 Millimeter
Outer Diameter2 Millimeter
Length14 Millimeter
Outer Diameter2 Millimeter
Length14 Millimeter
Outer Diameter2 Millimeter
Length14 Millimeter
Outer Diameter2 Millimeter
Length14 Millimeter
Outer Diameter2 Millimeter
Length14 Millimeter
Outer Diameter2 Millimeter
Length14 Millimeter
Outer Diameter2 Millimeter
Length14 Millimeter
Outer Diameter2 Millimeter
Length14 Millimeter
Outer Diameter2 Millimeter
Length14 Millimeter
Outer Diameter2 Millimeter
Length14 Millimeter
Outer Diameter2 Millimeter
Length14 Millimeter
Outer Diameter2 Millimeter
Length14 Millimeter
Outer Diameter2 Millimeter
Length14 Millimeter
Outer Diameter2 Millimeter
Length14 Millimeter
Outer Diameter2 Millimeter
Length14 Millimeter
Outer Diameter2 Millimeter
Length14 Millimeter
Outer Diameter2 Millimeter
Length14 Millimeter
Outer Diameter2 Millimeter
Length14 Millimeter
Outer Diameter2 Millimeter
Length14 Millimeter
Outer Diameter2 Millimeter
Length14 Millimeter
Outer Diameter2 Millimeter
Length14 Millimeter
Outer Diameter2 Millimeter
Length14 Millimeter
Outer Diameter2 Millimeter
Length14 Millimeter
Outer Diameter2 Millimeter
Length14 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100846832006984 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDWPIN, FIXATION, THREADED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00846832006984]

Moist Heat or Steam Sterilization


[00846832006984]

Moist Heat or Steam Sterilization


[00846832006984]

Moist Heat or Steam Sterilization


[00846832006984]

Moist Heat or Steam Sterilization


[00846832006984]

Moist Heat or Steam Sterilization


[00846832006984]

Moist Heat or Steam Sterilization


[00846832006984]

Moist Heat or Steam Sterilization


[00846832006984]

Moist Heat or Steam Sterilization


[00846832006984]

Moist Heat or Steam Sterilization


[00846832006984]

Moist Heat or Steam Sterilization


[00846832006984]

Moist Heat or Steam Sterilization


[00846832006984]

Moist Heat or Steam Sterilization


[00846832006984]

Moist Heat or Steam Sterilization


[00846832006984]

Moist Heat or Steam Sterilization


[00846832006984]

Moist Heat or Steam Sterilization


[00846832006984]

Moist Heat or Steam Sterilization


[00846832006984]

Moist Heat or Steam Sterilization


[00846832006984]

Moist Heat or Steam Sterilization


[00846832006984]

Moist Heat or Steam Sterilization


[00846832006984]

Moist Heat or Steam Sterilization


[00846832006984]

Moist Heat or Steam Sterilization


[00846832006984]

Moist Heat or Steam Sterilization


[00846832006984]

Moist Heat or Steam Sterilization


[00846832006984]

Moist Heat or Steam Sterilization


[00846832006984]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-12-07

On-Brand Devices [NexFix™ NCP System]

00846832007059NCP-N3530
00846832007042NCP-N3525
00846832007035NCP-N3520
00846832007028NCP-N2724
00846832007011NCP-N2720
00846832007004NCP-N2716
00846832006991NCP-N2016
00846832006984NCP-N2014
00846832006977NCP-N2012
00846832006960NCP-N2010
00846832006953NCP-N035

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