NexFix™ MTP Fusion System

GUDID 00846832006755

TORNIER, INC.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00846832006755
• NIH Device Record Key: 7f9122aa-e819-4466-b66a-edf9aec0ab1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NexFix™ MTP Fusion System
• Version Model Number: MTP-2728
• 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

Device Dimensions

• Length: 28 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.7 Millimeter
• Length: 28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832006755 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053408

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

[00846832006755]

Moist Heat or Steam Sterilization

[00846832006755]

Moist Heat or Steam Sterilization

[00846832006755]

Moist Heat or Steam Sterilization

[00846832006755]

Moist Heat or Steam Sterilization

[00846832006755]

Moist Heat or Steam Sterilization

[00846832006755]

Moist Heat or Steam Sterilization

[00846832006755]

Moist Heat or Steam Sterilization

[00846832006755]

Moist Heat or Steam Sterilization

[00846832006755]

Moist Heat or Steam Sterilization

[00846832006755]

Moist Heat or Steam Sterilization

[00846832006755]

Moist Heat or Steam Sterilization

[00846832006755]

Moist Heat or Steam Sterilization

[00846832006755]

Moist Heat or Steam Sterilization

[00846832006755]

Moist Heat or Steam Sterilization

[00846832006755]

Moist Heat or Steam Sterilization

[00846832006755]

Moist Heat or Steam Sterilization

[00846832006755]

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™ MTP Fusion System]

• 00846832006922: MTP-RS3R
• 00846832006915: MTP-RS3L
• 00846832006908: MTP-RS2R
• 00846832006892: MTP-RS2L
• 00846832006885: MTP-PS3R
• 00846832006878: MTP-PS3L
• 00846832006861: MTP-PS2R
• 00846832006854: MTP-PS2L
• 00846832006809: MTP-3220
• 00846832006793: MTP-3218
• 00846832006786: MTP-3216
• 00846832006779: MTP-3214
• 00846832006762: MTP-3212
• 00846832006755: MTP-2728
• 00846832006748: MTP-2724
• 00846832006731: MTP-2720
• 00846832006724: MTP-2718
• 00846832006717: MTP-2716
• 00846832006700: MTP-2714
• 00846832006694: MTP-2712