Construct® Ankle Fusion Plate System PSS4528CT

GUDID M269PSS4528CT1

Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.

Ascension Orthopedics, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: M269PSS4528CT1
• NIH Device Record Key: 764bb6c6-1d1b-4ac6-9f11-0206af6d226d
• Commercial Distribution Discontinuation: 2023-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Construct® Ankle Fusion Plate System
• Version Model Number: PSS4528CT
• Catalog Number: PSS4528CT
• 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
• 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 Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780117667 [Primary]
HIBCC	M269PSS4528CT1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100176

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[M269PSS4528CT1]

Moist Heat or Steam Sterilization

[M269PSS4528CT1]

Moist Heat or Steam Sterilization

[M269PSS4528CT1]

Moist Heat or Steam Sterilization

[M269PSS4528CT1]

Moist Heat or Steam Sterilization

[M269PSS4528CT1]

Moist Heat or Steam Sterilization

[M269PSS4528CT1]

Moist Heat or Steam Sterilization

[M269PSS4528CT1]

Moist Heat or Steam Sterilization

[M269PSS4528CT1]

Moist Heat or Steam Sterilization

[M269PSS4528CT1]

Moist Heat or Steam Sterilization

[M269PSS4528CT1]

Moist Heat or Steam Sterilization

[M269PSS4528CT1]

Moist Heat or Steam Sterilization

[M269PSS4528CT1]

Moist Heat or Steam Sterilization

[M269PSS4528CT1]

Moist Heat or Steam Sterilization

[M269PSS4528CT1]

Moist Heat or Steam Sterilization

[M269PSS4528CT1]

Moist Heat or Steam Sterilization

[M269PSS4528CT1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-05-02
• Device Publish Date: 2017-10-09

On-Brand Devices [Construct® Ankle Fusion Plate System]

• M268AFPIMP1: The Construct Ankle Fusion Plate System consists of two anterior tibia-talus and a lateral tibia
• M269PSS6580LT1: Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactur
• M269PSS6580CT1: Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufa
• M269PSS6575LT1: Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactur
• M269PSS6570LT1: Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactur
• M269PSS6570CT1: Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufa
• M269PSS6565LT1: Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactur
• M269PSS6565CT1: Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufa
• M269PSS6560LT1: Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactur
• M269PSS6560CT1: Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufa
• M269PSS6555CT1: Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufa
• M269PSS6550LT1: Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactur
• M269PSS6550CT1: Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufa
• M269PSS6545LT1: Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactur
• M269PSS6545CT1: Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufa
• M269PSS6540LT1: Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactur
• M269PSS6540CT1: Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufa
• M269PSS6538LT1: Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactur
• M269PSS6538CT1: Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufa
• M269PSS6536LT1: Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactur
• M269PSS6536CT1: Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufa
• M269PSS6534LT1: Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactur
• M269PSS6534CT1: Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufa
• M269PSS6532LT1: Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactur
• M269PSS6530LT1: Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactur
• M269PSS6530CT1: Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufa
• M269PSS6528LT1: Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactur
• M269PSS6526LT1: Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactur
• M269PSS6524LT1: Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactur
• M269PSS6522LT1: Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactur
• M269PSS6520LT1: Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactur
• M269PSS4580LT1: Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactur
• M269PSS4580CT1: Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufa
• M269PSS4575LT1: Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactur
• M269PSS4575CT1: Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufa
• M269PSS4570LT1: Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactur
• M269PSS4570CT1: Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufa
• M269PSS4565LT1: Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactur
• M269PSS4565CT1: Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufa
• M269PSS4560LT1: Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactur
• M269PSS4560CT1: Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufa
• M269PSS4555LT1: Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactur
• M269PSS4555CT1: Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufa
• M269PSS4550LT1: Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactur
• M269PSS4550CT1: Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufa
• M269PSS4545LT1: Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactur
• M269PSS4545CT1: Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufa
• M269PSS4540LT1: Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactur
• M269PSS4540CT1: Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufa
• M269PSS4538LT1: Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactur