StayFuse™

GUDID 00846832009626

TORNIER, INC.

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

• Primary Device ID: 00846832009626
• NIH Device Record Key: d8c15947-add3-4680-a590-93594c40fc2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StayFuse™
• Version Model Number: STA-D6
• 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: 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
• 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: 5 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 6 Millimeter
• Outer Diameter: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832009626 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022726

FDA Product Code

• HWC: Screw, fixation, bone

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 [StayFuse™]

• 00846832009688: STA-P4
• 00846832009671: STA-P3
• 00846832009664: STA-P2
• 00846832009657: STA-P1
• 00846832009640: STA-D8
• 00846832009633: STA-D7
• 00846832009626: STA-D6
• 00846832009619: STA-D5
• 00846832009602: STA-D4
• 00846832009596: STA-D3
• 00846832009589: STA-D2
• 00846832009572: STA-D1