Integra® BioMotion® Cannulated Hemi System HM2100

GUDID 10381780116387

The Integra® BioMotion® Cannulated Hemi implant is used with the Integra® BioMotion® Cannulated Hemi System as a partial joint replacement for the first metatarsophalangeal joint (MPJ). The Cannulated Implants are made from Titanium Alloy (ASTM F-136).

Ascension Orthopedics, Inc.

Total metatarsophalangeal joint prosthesis, one-piece

• Primary Device ID: 10381780116387
• NIH Device Record Key: f75838b2-3ef3-45d4-bfe4-8f28d2c3b872
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra® BioMotion® Cannulated Hemi System
• Version Model Number: HM2100
• Catalog Number: HM2100
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	10381780116387 [Primary]
HIBCC	M268HM21001 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083469

FDA Product Code

• KWD: PROSTHESIS, TOE, HEMI-, PHALANGEAL

Sterilization

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

[10381780116387]

Moist Heat or Steam Sterilization

[10381780116387]

Moist Heat or Steam Sterilization

[10381780116387]

Moist Heat or Steam Sterilization

[10381780116387]

Moist Heat or Steam Sterilization

[10381780116387]

Moist Heat or Steam Sterilization

[10381780116387]

Moist Heat or Steam Sterilization

[10381780116387]

Moist Heat or Steam Sterilization

[10381780116387]

Moist Heat or Steam Sterilization

[10381780116387]

Moist Heat or Steam Sterilization

[10381780116387]

Moist Heat or Steam Sterilization

[10381780116387]

Moist Heat or Steam Sterilization

[10381780116387]

Moist Heat or Steam Sterilization

[10381780116387]

Moist Heat or Steam Sterilization

[10381780116387]

Moist Heat or Steam Sterilization

[10381780116387]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-04-21
• Device Publish Date: 2017-10-09

On-Brand Devices [Integra® BioMotion® Cannulated Hemi System]

• 10381780116394: The Integra® BioMotion® Cannulated Hemi implant is used with the Integra® BioMotion® Cannu
• 10381780116387: The Integra® BioMotion® Cannulated Hemi implant is used with the Integra® BioMotion® Cannu
• 10381780116370: The Integra® BioMotion® Cannulated Hemi implant is used with the Integra® BioMotion® Cannu
• 10381780116363: The Integra® BioMotion® Cannulated Hemi implant is used with the Integra® BioMotion® Cannu
• 10381780116356: The Integra® BioMotion® Cannulated Hemi implant is used with the Integra® BioMotion® Cannu
• M268BIOMOTIONIMP1: The Integra BioMotion Cannulated Hemi System is a partial joint replacement system for the first