MaxLock Extreme™

GUDID 00846832053629

TORNIER, INC.

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

• Primary Device ID: 00846832053629
• NIH Device Record Key: bea3b7c6-407a-4619-b58a-63c765c352b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MaxLock Extreme™
• Version Model Number: PKT-002-H36B
• 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
• 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

• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter
• Outer Diameter: 36 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832053629 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123203

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

Moist Heat or Steam Sterilization

[00846832053629]

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: 2015-10-16

On-Brand Devices [MaxLock Extreme™]

• 00846832057658: VAR-032-35
• 00846832057627: VAR-032-24
• 00846832057603: VAR-031-35-65
• 00846832057597: VAR-031-35-60
• 00846832057580: VAR-031-35-55
• 00846832057573: VAR-031-35-50
• 00846832057566: VAR-031-35-48
• 00846832057559: VAR-031-35-46
• 00846832057542: VAR-031-35-44
• 00846832057535: VAR-031-35-42
• 00846832057528: VAR-031-35-40
• 00846832057511: VAR-031-35-38
• 00846832057504: VAR-031-35-36
• 00846832057498: VAR-031-35-34
• 00846832057481: VAR-031-35-32
• 00846832057474: VAR-031-35-30
• 00846832057467: VAR-031-35-28
• 00846832057450: VAR-031-35-26
• 00846832057443: VAR-031-35-24
• 00846832057436: VAR-031-35-22
• 00846832057429: VAR-031-35-20
• 00846832057412: VAR-031-35-18
• 00846832057405: VAR-031-35-16
• 00846832057399: VAR-031-35-14
• 00846832057382: VAR-031-35-12
• 00846832057375: VAR-031-35-10
• 00846832057351: VAR-031-27-65
• 00846832057344: VAR-031-27-60
• 00846832057337: VAR-031-27-55
• 00846832057320: VAR-031-27-50
• 00846832057313: VAR-031-27-45
• 00846832057306: VAR-031-27-40
• 00846832057290: VAR-031-27-38
• 00846832057283: VAR-031-27-36
• 00846832057276: VAR-031-27-34
• 00846832057269: VAR-031-27-32
• 00846832057252: VAR-031-27-30
• 00846832057245: VAR-031-27-28
• 00846832057238: VAR-031-27-26
• 00846832057221: VAR-031-27-24
• 00846832057214: VAR-031-27-22
• 00846832057207: VAR-031-27-20
• 00846832057191: VAR-031-27-18
• 00846832057184: VAR-031-27-16
• 00846832057177: VAR-031-27-14
• 00846832057160: VAR-031-27-12
• 00846832057153: VAR-031-27-10
• 00846832056798: TMT-002-23SR
• 00846832056781: TMT-002-23SL
• 00846832056774: TMT-002-23MR