Integra® Total Foot System 2807003

GUDID 10381780118374

The Integra Total Foot System Tarsalis Plate is a 3-hole straight utility plate used for fixation of osteotomies and fractures throughout the foot.

Ascension Orthopedics, Inc.

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 10381780118374
• NIH Device Record Key: 09f8603d-861c-4dd7-83e2-25f774f3a384
• Commercial Distribution Discontinuation: 2023-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Integra® Total Foot System
• Version Model Number: 2807003
• Catalog Number: 2807003
• 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: 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: +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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780118374 [Primary]
HIBCC	M26828070031 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100502

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

[10381780118374]

Moist Heat or Steam Sterilization

[10381780118374]

Moist Heat or Steam Sterilization

[10381780118374]

Moist Heat or Steam Sterilization

[10381780118374]

Moist Heat or Steam Sterilization

[10381780118374]

Moist Heat or Steam Sterilization

[10381780118374]

Moist Heat or Steam Sterilization

[10381780118374]

Moist Heat or Steam Sterilization

[10381780118374]

Moist Heat or Steam Sterilization

[10381780118374]

Moist Heat or Steam Sterilization

[10381780118374]

Moist Heat or Steam Sterilization

[10381780118374]

Moist Heat or Steam Sterilization

[10381780118374]

Moist Heat or Steam Sterilization

[10381780118374]

Moist Heat or Steam Sterilization

[10381780118374]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-05-03
• Device Publish Date: 2017-10-09

On-Brand Devices [Integra® Total Foot System]

• M26928021101: The Integra Total Foot System interpositioning plate is used to space apart two bones or a joint
• M26928130041: The Integra Total Foot System One Third Tubular Plate is a 4 -Hole straight utility plate used
• M26928120051: The Integra Total Foot System Fibular Plate is a 5-hole straight utility plate used for fixation
• M26928120041: The Integra Total Foot System Fibular Plate is a 4-hole straight utility plate used for fixation
• M26928321531: The Integra Total Foot System open wedge plate is used for fixation for a variety of proximal me
• M26928321521: The Integra Total Foot System open wedge plate is used for fixation for a variety of proximal me
• M26928330351: Washer used in conjunction with screws for Integra® Total Foot System
• M26928074031: The Integra Total Foot System Tarsalis Plate is a 4-hole diamond-shaped utility plate used for f
• 10381780119746: The Integra Total Foot System Tarsalis Plate is a 4-hole crescentic utility plate used for fixa
• M26928072021: The Integra Total Foot System Tarsalis Plate is a 4-hole crescentic utility plate used for fixa
• M26928082081: The Integra Total Foot System Tarsalis Plate is a 8-hole T-shaped utility plate used for fixatio
• M26928082061: The Integra Total Foot System Tarsalis Plate is a 6-hole T-shaped utility plate used for fixatio
• M26928082051: The Integra Total Foot System Tarsalis Plate is a 5-hole T-shaped utility plate used for fixatio
• M26928081061: The Integra Total Foot System Tarsalis Plate is a 6-hole T-shaped utility plate used for fixatio
• M26928081051: The Integra Total Foot System Tarsalis Plate is a 5-hole T-shaped utility plate used for fixatio
• M26928062101: The Integra Total Foot System Dwyer Displacement Plate has an in step design to stabilize medial
• M26928140061: The Integra Total Foot System Flatline Arthrodesis Plate provides optimum stability for a variet
• M26928140041: The Integra Total Foot System Flatline Arthrodesis Plate provides optimum stability for a variet
• M26928030091: The Integra Total Foot System Rearfoot Reconstruction Plate is a 9-hole plate used for reconstru
• M26928030071: The Integra Total Foot System Rearfoot Reconstruction Plate is a 7-hole plate used for reconstru
• M26928021001: The Integra Total Foot System interpositioning plate is used to space apart two bones or a joint
• 10381780119432: The Integra Total Foot System Universal Forefoot Plate is a 4-hole plate designed to stabilize a
• 10381780119418: The Integra Total Foot System Universal Forefoot Plate is a 4-hole plate designed to stabilize a
• 10381780119395: The Integra Total Foot System Universal Forefoot Plate is a 4-hole plate designed to stabilize a
• 10381780119388: The Integra Total Foot System Universal Forefoot Plate is a 4-hole plate designed to stabilize a
• M26928020221: The Integra Total Foot System Universal Rearfoot Plate is a 4-hole plate designed to stabilize a
• M26928020201: The Integra Total Foot System Universal Rearfoot Plate is a 4-hole plate designed to stabilize a
• M26928020181: The Integra Total Foot System Universal Rearfoot Plate is a 4-hole plate designed to stabilize a
• M26928020141: The Integra Total Foot System Universal Rearfoot Plate is a 4-hole plate designed to stabilize a
• M26928011041: The Integra Total Foot System Lapidus Plate is used for the rear foot. The step on the plate ens
• M26928011031: The Integra Total Foot System Lapidus Plate is used for the rear foot. The step on the plate ens
• M26928011011: The Integra Total Foot System Lapidus Plate is used for the rear foot. The step on the plate ens
• 10381780119166: The standard forefoot screw is used in the Integra Total Foot System. It is made from titanium a
• 10381780119159: The standard forefoot screw is used in the Integra Total Foot System. It is made from titanium a
• 10381780119128: The standard forefoot screw is used in the Integra Total Foot System. It is made from titanium a
• 10381780119111: The standard forefoot screw is used in the Integra Total Foot System. It is made from titanium a
• 10381780119104: The standard forefoot screw is used in the Integra Total Foot System. It is made from titanium a
• 10381780119081: The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
• 10381780119050: The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
• 10381780119012: The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
• 10381780119005: The standard forefoot screw is used in the Integra Total Foot System. It is made from titanium a
• 10381780118992: The standard forefoot screw is used in the Integra Total Foot System. It is made from titanium a
• 10381780118985: The standard forefoot screw is used in the Integra Total Foot System. It is made from titanium a
• 10381780118923: The standard forefoot screw is used in the Integra Total Foot System. It is made from titanium a
• 10381780118909: The standard forefoot screw is used in the Integra Total Foot System. It is made from titanium a
• 10381780118886: The standard forefoot screw is used in the Integra Total Foot System. It is made from titanium a
• 10381780118862: The standard forefoot screw is used in the Integra Total Foot System. It is made from titanium a
• 10381780118848: The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
• 10381780118817: The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.
• 10381780118800: The locking forefoot screw is used in the Integra Total Foot System. It is made from titanium.