AcuTie II

GUDID 10814493010661

AcuTie Two Sternum Plate

ACUTE INNOVATIONS LLC

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: 10814493010661
• NIH Device Record Key: 8c4ce191-8600-4cbd-bdce-678e1b31acd6
• Commercial Distribution Discontinuation: 2021-03-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AcuTie II
• Version Model Number: STW1104
• Company DUNS: 619225415
• Company Name: ACUTE INNOVATIONS LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18666234137
• Email: customerservice@acuteinnovations.com
• Phone: 18666234137
• Email: customerservice@acuteinnovations.com
• Phone: 18666234137
• Email: customerservice@acuteinnovations.com
• Phone: 18666234137
• Email: customerservice@acuteinnovations.com
• Phone: 18666234137
• Email: customerservice@acuteinnovations.com
• Phone: 18666234137
• Email: customerservice@acuteinnovations.com
• Phone: 18666234137
• Email: customerservice@acuteinnovations.com
• Phone: 18666234137
• Email: customerservice@acuteinnovations.com
• Phone: 18666234137
• Email: customerservice@acuteinnovations.com
• Phone: 18666234137
• Email: customerservice@acuteinnovations.com
• Phone: 18666234137
• Email: customerservice@acuteinnovations.com
• Phone: 18666234137
• Email: customerservice@acuteinnovations.com
• Phone: 18666234137
• Email: customerservice@acuteinnovations.com
• Phone: 18666234137
• Email: customerservice@acuteinnovations.com
• Phone: 18666234137
• Email: customerservice@acuteinnovations.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10814493010661 [Primary]

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[10814493010661]

Moist Heat or Steam Sterilization

[10814493010661]

Moist Heat or Steam Sterilization

[10814493010661]

Moist Heat or Steam Sterilization

[10814493010661]

Moist Heat or Steam Sterilization

[10814493010661]

Moist Heat or Steam Sterilization

[10814493010661]

Moist Heat or Steam Sterilization

[10814493010661]

Moist Heat or Steam Sterilization

[10814493010661]

Moist Heat or Steam Sterilization

[10814493010661]

Moist Heat or Steam Sterilization

[10814493010661]

Moist Heat or Steam Sterilization

[10814493010661]

Moist Heat or Steam Sterilization

[10814493010661]

Moist Heat or Steam Sterilization

[10814493010661]

Moist Heat or Steam Sterilization

[10814493010661]

Moist Heat or Steam Sterilization

[10814493010661]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-04-12
• Device Publish Date: 2015-09-16

Devices Manufactured by ACUTE INNOVATIONS LLC

• 10814493010012 - RibLoc: 2021-04-12 8mm x 46mm Rib Plate
• 10814493010029 - RibLoc: 2021-04-12 10mm x 46mm Rib Plate
• 10814493010036 - RibLoc: 2021-04-12 12mm x 46mm Rib Plate
• 10814493010043 - RibLoc: 2021-04-12 14mm x 46mm Rib Plate
• 10814493010050 - RibLoc: 2021-04-12 8mm x 61mm Rib Plate
• 10814493010067 - RibLoc: 2021-04-12 10mm x 61mm Rib Plate
• 10814493010074 - RibLoc: 2021-04-12 12mm x 61mm Rib Plate
• 10814493010081 - RibLoc: 2021-04-12 14mm x 61mm Rib Plate