Integra® DigiFuse® Implant System DIGIFUSEIMP2

GUDID M268DIGIFUSEIMP21

The Integra DigiFuse Implant is a one-piece threaded device intended to be implanted into the medullary bone of the lesser toes. The implant is offered in several variations consisting of the combination of 2.0mm and 2.5mm, 0° and 10° blades, as well as standard and short blade options. A 2.0mm x 0° mini-blade is also offered for DIP fusions and smaller anatomy. The system includes instruments to facilitate the placement of the implants. All implants are made from Titanium Alloy, and instrumentation is made from titanium and stainless steel. The DigiFuse implant is indicated for the fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers.

Ascension Orthopedics, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: M268DIGIFUSEIMP21
• NIH Device Record Key: f392e211-a61f-4a58-a383-0bb6b6395460
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra® DigiFuse® Implant System
• Version Model Number: DIGIFUSEIMP2
• Catalog Number: DIGIFUSEIMP2
• Company DUNS: 942377524
• Company Name: Ascension Orthopedics, 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780074281 [Primary]
HIBCC	M268DIGIFUSEIMP21 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111536

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[M268DIGIFUSEIMP21]

Moist Heat or Steam Sterilization

[M268DIGIFUSEIMP21]

Moist Heat or Steam Sterilization

[M268DIGIFUSEIMP21]

Moist Heat or Steam Sterilization

[M268DIGIFUSEIMP21]

Moist Heat or Steam Sterilization

[M268DIGIFUSEIMP21]

Moist Heat or Steam Sterilization

[M268DIGIFUSEIMP21]

Moist Heat or Steam Sterilization

[M268DIGIFUSEIMP21]

Moist Heat or Steam Sterilization

[M268DIGIFUSEIMP21]

Moist Heat or Steam Sterilization

[M268DIGIFUSEIMP21]

Moist Heat or Steam Sterilization

[M268DIGIFUSEIMP21]

Moist Heat or Steam Sterilization

[M268DIGIFUSEIMP21]

Moist Heat or Steam Sterilization

[M268DIGIFUSEIMP21]

Moist Heat or Steam Sterilization

[M268DIGIFUSEIMP21]

Moist Heat or Steam Sterilization

[M268DIGIFUSEIMP21]

Moist Heat or Steam Sterilization

[M268DIGIFUSEIMP21]

Moist Heat or Steam Sterilization

[M268DIGIFUSEIMP21]

Moist Heat or Steam Sterilization

[M268DIGIFUSEIMP21]

Moist Heat or Steam Sterilization

[M268DIGIFUSEIMP21]

Moist Heat or Steam Sterilization

[M268DIGIFUSEIMP21]

Moist Heat or Steam Sterilization

[M268DIGIFUSEIMP21]

Moist Heat or Steam Sterilization

[M268DIGIFUSEIMP21]

Moist Heat or Steam Sterilization

[M268DIGIFUSEIMP21]

Moist Heat or Steam Sterilization

[M268DIGIFUSEIMP21]

Moist Heat or Steam Sterilization

[M268DIGIFUSEIMP21]

Moist Heat or Steam Sterilization

[M268DIGIFUSEIMP21]

Moist Heat or Steam Sterilization

[M268DIGIFUSEIMP21]

Moist Heat or Steam Sterilization

[M268DIGIFUSEIMP21]

Moist Heat or Steam Sterilization

[M268DIGIFUSEIMP21]

Moist Heat or Steam Sterilization

[M268DIGIFUSEIMP21]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-07-16
• Device Publish Date: 2015-09-22

Devices Manufactured by Ascension Orthopedics, Inc.

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• 10381780123040 - CAPTURE™ High Torque Screw System: 2023-09-18 The washer is used in conjunction with the Capture High Torque Screw System.
• 10381780123057 - CAPTURE™ High Torque Screw System: 2023-09-18 The washer is used in conjunction with the Capture High Torque Screw System.
• 10381780123064 - CAPTURE™ High Torque Screw System: 2023-09-18 The washer is used in conjunction with the Capture High Torque Screw System.
• M26922286111 - Integra®: 2023-09-18 Integra® Total Foot System K-Wire is used for temporary fixation.