Mini MaxTorque™

GUDID 00846832034307

TORNIER, INC.

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

• Primary Device ID: 00846832034307
• NIH Device Record Key: 292442d9-4fc1-406a-b40c-f4524aef79a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mini MaxTorque™
• Version Model Number: HCS-010-38-45S
• 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

• Outer Diameter: 3.8 Millimeter
• Outer Diameter: 3.8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 3.8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 3.8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 3.8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 3.8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 3.8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 3.8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 3.8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 3.8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 3.8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 3.8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 3.8 Millimeter
• Length: 45 Millimeter
• Outer Diameter: 3.8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832034307 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082574

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00846832034307]

Moist Heat or Steam Sterilization

[00846832034307]

Moist Heat or Steam Sterilization

[00846832034307]

Moist Heat or Steam Sterilization

[00846832034307]

Moist Heat or Steam Sterilization

[00846832034307]

Moist Heat or Steam Sterilization

[00846832034307]

Moist Heat or Steam Sterilization

[00846832034307]

Moist Heat or Steam Sterilization

[00846832034307]

Moist Heat or Steam Sterilization

[00846832034307]

Moist Heat or Steam Sterilization

[00846832034307]

Moist Heat or Steam Sterilization

[00846832034307]

Moist Heat or Steam Sterilization

[00846832034307]

Moist Heat or Steam Sterilization

[00846832034307]

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 [Mini MaxTorque™]

• 00846832054008: SP-HCS-001
• 00846832034345: HCS-010-38-50S
• 00846832034338: HCS-010-38-50L
• 00846832034321: HCS-010-38-475S
• 00846832034314: HCS-010-38-475L
• 00846832034307: HCS-010-38-45S
• 00846832034291: HCS-010-38-45L
• 00846832034284: HCS-010-38-425S
• 00846832034277: HCS-010-38-425L
• 00846832034260: HCS-010-38-40S
• 00846832034253: HCS-010-38-40L
• 00846832034239: HCS-010-38-38S
• 00846832034222: HCS-010-38-38L
• 00846832034208: HCS-010-38-36S
• 00846832034192: HCS-010-38-36L
• 00846832034178: HCS-010-38-34S
• 00846832034161: HCS-010-38-34L
• 00846832034147: HCS-010-38-32S
• 00846832034130: HCS-010-38-32L
• 00846832034116: HCS-010-38-30S
• 00846832034109: HCS-010-38-30L
• 00846832034086: HCS-010-38-28S
• 00846832034079: HCS-010-38-28L
• 00846832034055: HCS-010-38-26S
• 00846832034048: HCS-010-38-26L
• 00846832034024: HCS-010-38-24S
• 00846832034017: HCS-010-38-24L
• 00846832033997: HCS-010-38-22S
• 00846832033980: HCS-010-38-22L
• 00846832033966: HCS-010-38-20S
• 00846832033959: HCS-010-38-20L
• 00846832033935: HCS-010-38-18S
• 00846832033928: HCS-010-38-18L
• 00846832033904: HCS-010-38-16S
• 00846832033898: HCS-010-38-16L
• 00846832033874: HCS-010-32-38S
• 00846832033867: HCS-010-32-38L
• 00846832033843: HCS-010-32-36S
• 00846832033836: HCS-010-32-36L
• 00846832033812: HCS-010-32-34S
• 00846832033805: HCS-010-32-34L
• 00846832033782: HCS-010-32-32S
• 00846832033775: HCS-010-32-32L
• 00846832033751: HCS-010-32-30S
• 00846832033744: HCS-010-32-30L
• 00846832033720: HCS-010-32-28S
• 00846832033713: HCS-010-32-28L
• 00846832033690: HCS-010-32-26S
• 00846832033683: HCS-010-32-26L
• 00846832033669: HCS-010-32-24S