Integra Stainless Headed Compression Screw System HEADHNDSET

GUDID 10381780064619

The Headed Compression Screw System contains compression screws used with the Ankle Fusion Plating System. This set includes screws with diamter 6.5mm or 7.5mm.

Ascension Orthopedics, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 10381780064619
• NIH Device Record Key: 9562543b-76b5-447e-b31c-21346620b7d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra Stainless Headed Compression Screw System
• Version Model Number: HEADHNDSET
• Catalog Number: HEADHNDSET
• 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	10381780064619 [Primary]
HIBCC	M268HEADHNDSET1 [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

[10381780064619]

Moist Heat or Steam Sterilization

[10381780064619]

Moist Heat or Steam Sterilization

[10381780064619]

Moist Heat or Steam Sterilization

[10381780064619]

Moist Heat or Steam Sterilization

[10381780064619]

Moist Heat or Steam Sterilization

[10381780064619]

Moist Heat or Steam Sterilization

[10381780064619]

Moist Heat or Steam Sterilization

[10381780064619]

Moist Heat or Steam Sterilization

[10381780064619]

Moist Heat or Steam Sterilization

[10381780064619]

Moist Heat or Steam Sterilization

[10381780064619]

Moist Heat or Steam Sterilization

[10381780064619]

Moist Heat or Steam Sterilization

[10381780064619]

Moist Heat or Steam Sterilization

[10381780064619]

Moist Heat or Steam Sterilization

[10381780064619]

Moist Heat or Steam Sterilization

[10381780064619]

Moist Heat or Steam Sterilization

[10381780064619]

Moist Heat or Steam Sterilization

[10381780064619]

Moist Heat or Steam Sterilization

[10381780064619]

Moist Heat or Steam Sterilization

[10381780064619]

Moist Heat or Steam Sterilization

[10381780064619]

Moist Heat or Steam Sterilization

[10381780064619]

Moist Heat or Steam Sterilization

[10381780064619]

Moist Heat or Steam Sterilization

[10381780064619]

Moist Heat or Steam Sterilization

[10381780064619]

Moist Heat or Steam Sterilization

[10381780064619]

Moist Heat or Steam Sterilization

[10381780064619]

Moist Heat or Steam Sterilization

[10381780064619]

Moist Heat or Steam Sterilization

[10381780064619]

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

On-Brand Devices [Integra Stainless Headed Compression Screw System]

• 10381780064619: The Headed Compression Screw System contains compression screws used with the Ankle Fusion Plati
• 10381780064602: The Headed Compression Screw System contains compression screws used with the Ankle Fusion Plati