OrthoLink™

GUDID 00846832041688

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

• Primary Device ID: 00846832041688
• NIH Device Record Key: a48a5ab4-8e24-4b3f-bf38-9de8406470a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoLink™
• Version Model Number: MOW-002-5
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832041688 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073624

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

[00846832041688]

Moist Heat or Steam Sterilization

[00846832041688]

Moist Heat or Steam Sterilization

[00846832041688]

Moist Heat or Steam Sterilization

[00846832041688]

Moist Heat or Steam Sterilization

[00846832041688]

Moist Heat or Steam Sterilization

[00846832041688]

Moist Heat or Steam Sterilization

[00846832041688]

Moist Heat or Steam Sterilization

[00846832041688]

Moist Heat or Steam Sterilization

[00846832041688]

Moist Heat or Steam Sterilization

[00846832041688]

Moist Heat or Steam Sterilization

[00846832041688]

Moist Heat or Steam Sterilization

[00846832041688]

Moist Heat or Steam Sterilization

[00846832041688]

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 [OrthoLink™]

• 00846832041695: MOW-002-6
• 00846832041688: MOW-002-5
• 00846832041671: MOW-002-4
• 00846832041664: MOW-002-3
• 00846832041657: MOW-002-2
• 00846832039609: MFT-002-4PLKG
• 00846832028795: COW-002-12
• 00846832028788: COW-002-10
• 00846832028771: COW-002-08
• 00846832028764: COW-002-07
• 00846832028757: COW-002-06
• 00846832028740: COW-002-05
• 00846832028733: COW-002-04
• 00846832028726: COW-002-02