NexFix™ NCP System

GUDID 00846832007011

TORNIER, INC.

Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: 00846832007011
• NIH Device Record Key: e72c8d6d-a777-4e50-b54f-01da4a6e4788
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NexFix™ NCP System
• Version Model Number: NCP-N2720
• Company DUNS: 968990812
• Company Name: TORNIER, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com
• Phone: +1(888)494-7950
• Email: customerservice@tornier.com

Device Dimensions

• Length: 20 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 20 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832007011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072710

FDA Product Code

• JDW: PIN, FIXATION, THREADED

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00846832007011]

Moist Heat or Steam Sterilization

[00846832007011]

Moist Heat or Steam Sterilization

[00846832007011]

Moist Heat or Steam Sterilization

[00846832007011]

Moist Heat or Steam Sterilization

[00846832007011]

Moist Heat or Steam Sterilization

[00846832007011]

Moist Heat or Steam Sterilization

[00846832007011]

Moist Heat or Steam Sterilization

[00846832007011]

Moist Heat or Steam Sterilization

[00846832007011]

Moist Heat or Steam Sterilization

[00846832007011]

Moist Heat or Steam Sterilization

[00846832007011]

Moist Heat or Steam Sterilization

[00846832007011]

Moist Heat or Steam Sterilization

[00846832007011]

Moist Heat or Steam Sterilization

[00846832007011]

Moist Heat or Steam Sterilization

[00846832007011]

Moist Heat or Steam Sterilization

[00846832007011]

Moist Heat or Steam Sterilization

[00846832007011]

Moist Heat or Steam Sterilization

[00846832007011]

Moist Heat or Steam Sterilization

[00846832007011]

Moist Heat or Steam Sterilization

[00846832007011]

Moist Heat or Steam Sterilization

[00846832007011]

Moist Heat or Steam Sterilization

[00846832007011]

Moist Heat or Steam Sterilization

[00846832007011]

Moist Heat or Steam Sterilization

[00846832007011]

Moist Heat or Steam Sterilization

[00846832007011]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-12-07

On-Brand Devices [NexFix™ NCP System]

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