Collagen Meniscus Implant CMI® 4300

GUDID M92843001

IVY SPORTS MEDICINE LLC

Meniscus biomatrix implant, animal-derived Meniscus biomatrix implant, animal-derived Meniscus biomatrix implant, animal-derived Meniscus biomatrix implant, animal-derived Meniscus biomatrix implant, animal-derived Meniscus biomatrix implant, animal-derived Meniscus biomatrix implant, animal-derived Meniscus biomatrix implant, animal-derived Meniscus biomatrix implant, animal-derived Meniscus biomatrix implant, animal-derived Meniscus biomatrix implant, animal-derived Meniscus biomatrix implant, animal-derived Meniscus biomatrix implant, animal-derived Meniscus biomatrix implant, animal-derived Meniscus biomatrix implant, animal-derived Meniscus biomatrix implant, animal-derived

• Primary Device ID: M92843001
• NIH Device Record Key: a7bc39b0-2c6c-4a1b-a1dd-417c69398574
• Commercial Distribution Discontinuation: 2018-08-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Collagen Meniscus Implant CMI®
• Version Model Number: Medial 7.5 mm
• Catalog Number: 4300
• Company DUNS: 046226406
• Company Name: IVY SPORTS MEDICINE LLC
• 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: true
• 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: 1-800-624-4422
• Email: endocustomersupport@stryker.com
• Phone: 1-800-624-4422
• Email: endocustomersupport@stryker.com
• Phone: 1-800-624-4422
• Email: endocustomersupport@stryker.com
• Phone: 1-800-624-4422
• Email: endocustomersupport@stryker.com
• Phone: 1-800-624-4422
• Email: endocustomersupport@stryker.com
• Phone: 1-800-624-4422
• Email: endocustomersupport@stryker.com
• Phone: 1-800-624-4422
• Email: endocustomersupport@stryker.com
• Phone: 1-800-624-4422
• Email: endocustomersupport@stryker.com
• Phone: 1-800-624-4422
• Email: endocustomersupport@stryker.com
• Phone: 1-800-624-4422
• Email: endocustomersupport@stryker.com
• Phone: 1-800-624-4422
• Email: endocustomersupport@stryker.com
• Phone: 1-800-624-4422
• Email: endocustomersupport@stryker.com
• Phone: 1-800-624-4422
• Email: endocustomersupport@stryker.com
• Phone: 1-800-624-4422
• Email: endocustomersupport@stryker.com
• Phone: 1-800-624-4422
• Email: endocustomersupport@stryker.com
• Phone: 1-800-624-4422
• Email: endocustomersupport@stryker.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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M92843001 [Primary]

FDA Product Code

• OLC: Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-11-23
• Device Publish Date: 2015-10-24

On-Brand Devices [Collagen Meniscus Implant CMI®]

• M92843021: Medial XL
• M92843011: Medial 9.0 mm
• M92843001: Medial 7.5 mm