HITCH L15 905947

GUDID 00880304563827

Biomet Sports Medicine, LLC

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 00880304563827
• NIH Device Record Key: 0120c101-45a8-4804-90a5-a6f220a7f45e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HITCH L15
• Version Model Number: 905947
• Catalog Number: 905947
• Company DUNS: 627100159
• Company Name: Biomet 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)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304563827 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061389

FDA Product Code

• MBI: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

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: 2019-03-21
• Device Publish Date: 2015-10-24

On-Brand Devices [HITCH L15]

• 00880304563834: 905948
• 00880304563827: 905947