DRLock Extreme™

GUDID 00846832031528

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 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: 00846832031528
• NIH Device Record Key: 740a0b2b-0041-4fb0-a9ba-3c81a5946d19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DRLock Extreme™
• Version Model Number: DRE-121-20-16
• 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

Device Dimensions

• Length: 16 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 16 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832031528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102156

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00846832031528]

Moist Heat or Steam Sterilization

[00846832031528]

Moist Heat or Steam Sterilization

[00846832031528]

Moist Heat or Steam Sterilization

[00846832031528]

Moist Heat or Steam Sterilization

[00846832031528]

Moist Heat or Steam Sterilization

[00846832031528]

Moist Heat or Steam Sterilization

[00846832031528]

Moist Heat or Steam Sterilization

[00846832031528]

Moist Heat or Steam Sterilization

[00846832031528]

Moist Heat or Steam Sterilization

[00846832031528]

Moist Heat or Steam Sterilization

[00846832031528]

Moist Heat or Steam Sterilization

[00846832031528]

Moist Heat or Steam Sterilization

[00846832031528]

Moist Heat or Steam Sterilization

[00846832031528]

Moist Heat or Steam Sterilization

[00846832031528]

Moist Heat or Steam Sterilization

[00846832031528]

Moist Heat or Steam Sterilization

[00846832031528]

Moist Heat or Steam Sterilization

[00846832031528]

Moist Heat or Steam Sterilization

[00846832031528]

Moist Heat or Steam Sterilization

[00846832031528]

Moist Heat or Steam Sterilization

[00846832031528]

Moist Heat or Steam Sterilization

[00846832031528]

Moist Heat or Steam Sterilization

[00846832031528]

Moist Heat or Steam Sterilization

[00846832031528]

Moist Heat or Steam Sterilization

[00846832031528]

Moist Heat or Steam Sterilization

[00846832031528]

Moist Heat or Steam Sterilization

[00846832031528]

Moist Heat or Steam Sterilization

[00846832031528]

Moist Heat or Steam Sterilization

[00846832031528]

Moist Heat or Steam Sterilization

[00846832031528]

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 [DRLock Extreme™]

• 00846832058402: DRE-121-20-08
• 00846832058396: DRE-121-20-06
• 00846832031597: DRE-121-20-30
• 00846832031580: DRE-121-20-28
• 00846832031573: DRE-121-20-26
• 00846832031566: DRE-121-20-24
• 00846832031559: DRE-121-20-22
• 00846832031542: DRE-121-20-20
• 00846832031535: DRE-121-20-18
• 00846832031528: DRE-121-20-16
• 00846832031511: DRE-121-20-14
• 00846832031504: DRE-121-20-12
• 00846832031498: DRE-121-20-10
• 00846832031245: DRE-002-1R
• 00846832031238: DRE-002-1NR
• 00846832031221: DRE-002-1NL
• 00846832031214: DRE-002-1L
• 00846832031207: DRE-002-0R
• 00846832031191: DRE-002-0NR
• 00846832031184: DRE-002-0NL
• 00846832031177: DRE-002-0L