MaxTorque™

GUDID 00846832054633

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 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: 00846832054633
• NIH Device Record Key: 91530047-695b-4091-a601-21679e7786b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MaxTorque™
• Version Model Number: SP-MSD-55-425F
• 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
• 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

• Length: 42.5 Millimeter
• Length: 42.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 42.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 42.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 42.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 42.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 42.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 42.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 42.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 42.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 42.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 42.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 42.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 42.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 42.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 42.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 42.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 42.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846832054633 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060428

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00846832054633]

Moist Heat or Steam Sterilization

[00846832054633]

Moist Heat or Steam Sterilization

[00846832054633]

Moist Heat or Steam Sterilization

[00846832054633]

Moist Heat or Steam Sterilization

[00846832054633]

Moist Heat or Steam Sterilization

[00846832054633]

Moist Heat or Steam Sterilization

[00846832054633]

Moist Heat or Steam Sterilization

[00846832054633]

Moist Heat or Steam Sterilization

[00846832054633]

Moist Heat or Steam Sterilization

[00846832054633]

Moist Heat or Steam Sterilization

[00846832054633]

Moist Heat or Steam Sterilization

[00846832054633]

Moist Heat or Steam Sterilization

[00846832054633]

Moist Heat or Steam Sterilization

[00846832054633]

Moist Heat or Steam Sterilization

[00846832054633]

Moist Heat or Steam Sterilization

[00846832054633]

Moist Heat or Steam Sterilization

[00846832054633]

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 [MaxTorque™]

• 00846832058686: SP-MSD-55-110F
• 00846832058679: SP-MSD-55-105F
• 00846832058662: SP-MSD-55-100F
• 00846832058655: SP-MSD-55-095F
• 00846832058648: SP-MSD-55-090F
• 00846832058631: SP-MSD-55-085F
• 00846832058624: SP-MSD-55-080F
• 00846832058617: SP-MSD-55-075F
• 00846832058600: SP-MSD-40-070F
• 00846832058594: SP-MSD-40-065F
• 00846832058587: SP-MSD-40-060F
• 00846832058570: SP-MSD-40-055F
• 00846832058563: MSD-010-55-475P
• 00846832058556: MSD-010-55-110P
• 00846832058549: MSD-010-55-105P
• 00846832058532: MSD-010-55-100P
• 00846832058525: MSD-010-55-095P
• 00846832058518: MSD-010-55-090P
• 00846832058501: MSD-010-55-085P
• 00846832058495: MSD-010-55-080P
• 00846832058488: MSD-010-55-075P
• 00846832058471: MSD-010-55-070P
• 00846832058464: MSD-010-55-065P
• 00846832058457: MSD-010-55-060P
• 00846832058440: MSD-010-55-055P
• 00846832058433: MSD-010-55-050P
• 00846832058426: MSD-010-55-045P
• 00846832058419: MSD-010-55-040P
• 00846832054879: SP-MSD-70-475F
• 00846832054862: SP-MSD-70-425F
• 00846832054855: SP-MSD-70-375F
• 00846832054848: SP-MSD-70-130F
• 00846832054831: SP-MSD-70-125F
• 00846832054824: SP-MSD-70-120F
• 00846832054817: SP-MSD-70-115F
• 00846832054800: SP-MSD-70-110F
• 00846832054794: SP-MSD-70-105F
• 00846832054787: SP-MSD-70-100F
• 00846832054770: SP-MSD-70-095F
• 00846832054763: SP-MSD-70-090F
• 00846832054756: SP-MSD-70-085F
• 00846832054749: SP-MSD-70-080F
• 00846832054732: SP-MSD-70-075F
• 00846832054725: SP-MSD-70-070F
• 00846832054718: SP-MSD-70-065F
• 00846832054701: SP-MSD-70-060F
• 00846832054695: SP-MSD-70-055F
• 00846832054688: SP-MSD-70-050F
• 00846832054671: SP-MSD-70-045F
• 00846832054664: SP-MSD-70-040F