Insite™ FT Biocomposite

GUDID 00846832011483

TORNIER, INC.

Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 00846832011483
• NIH Device Record Key: c6630d5d-8825-41c8-b1cc-098869d35c4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Insite™ FT Biocomposite
• Version Model Number: SMB000505
• 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

Device Dimensions

• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832011483 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122635

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: 5
• Public Version Date: 2019-03-21
• Device Publish Date: 2015-10-16

On-Brand Devices [Insite™ FT Biocomposite]

• 00846832011506: SMB000605
• 00846832011490: SMB000515
• 00846832011483: SMB000505
• 00846832011476: SMB000415
• 00846832011469: SMB000405