Integra® MemoFix® MS201515

GUDID M268MS2015151

The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation device intended to be permanently implanted. The device is indicated for the fixation of osteotomies and joint arthrodesis of the hands and feet. The implant consists of two legs connected by a bridge and is offered in multiple combinations of bridge widths and leg lengths to accommodate various anatomies.

Ascension Orthopedics, Inc.

Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable, sterile Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable

• Primary Device ID: M268MS2015151
• NIH Device Record Key: 1f2157e0-bc42-4a67-ba2a-031f802f5d9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra® MemoFix®
• Version Model Number: MS201515
• Catalog Number: MS201515
• 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
• 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
• 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 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 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 Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780121480 [Primary]
HIBCC	M268MS2015151 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123926

FDA Product Code

• JDR: STAPLE, FIXATION, BONE

Sterilization

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

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

[M268MS2015151]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-11-10
• Device Publish Date: 2017-10-09

On-Brand Devices [Integra® MemoFix®]

• M268STAPLEIMP1: The Integra MemoFix staple is a one piece single use nickel titanium alloy bone fixation device
• M268MS2522221: The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev
• M268MS2520201: The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev
• M268MS2020201: The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev
• M268MS2015151: The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev
• M268MS1819171: The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev
• M268MS1817151: The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev
• M268MS1814141: The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev
• M268MS1812121: The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev
• M268MS1515151: The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev
• M268MS1512121: The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev
• M268MS1219161: The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev
• M268MS1217151: The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev
• M268MS1215131: The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev
• M268MS1210101: The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev
• M268MS1017151: The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev
• M268MS1015131: The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev
• M268MS1010101: The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev
• M268MS0808081: The Integra® MemoFix® staple is a one piece single use nickel titanium alloy bone fixation dev