Ankle Suture Button

GUDID 00846832056682

TORNIER, INC.

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

• Primary Device ID: 00846832056682
• NIH Device Record Key: 89aec8d6-8bf5-4f69-b274-1c1e17d1df07
• Commercial Distribution Discontinuation: 2017-04-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Ankle Suture Button
• Version Model Number: SYN-001-02
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832056682 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132733

FDA Product Code

• HTN: WASHER, BOLT NUT

Sterilization

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

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 [Ankle Suture Button]

• 00846832056682: SYN-001-02
• 00846832056651: SYN-001-01