Summit Patella Plating System 1316-3000

GUDID 00860004838005

Sterile, Single use, Patella Fracture Repair Kit, Standard

Endeavor Orthopaedics, LLC

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

• Primary Device ID: 00860004838005
• NIH Device Record Key: ffd295f5-b905-4016-92b3-be3a1021cf0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Summit Patella Plating System
• Version Model Number: Standard
• Catalog Number: 1316-3000
• Company DUNS: 107767417
• Company Name: Endeavor Orthopaedics, 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: true
• 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: 1-800-405-8862
• Email: info@endeavorortho.com
• Phone: 1-800-405-8862
• Email: info@endeavorortho.com
• Phone: 1-800-405-8862
• Email: info@endeavorortho.com
• Phone: 1-800-405-8862
• Email: info@endeavorortho.com
• Phone: 1-800-405-8862
• Email: info@endeavorortho.com
• Phone: 1-800-405-8862
• Email: info@endeavorortho.com
• Phone: 1-800-405-8862
• Email: info@endeavorortho.com
• Phone: 1-800-405-8862
• Email: info@endeavorortho.com
• Phone: 1-800-405-8862
• Email: info@endeavorortho.com
• Phone: 1-800-405-8862
• Email: info@endeavorortho.com
• Phone: 1-800-405-8862
• Email: info@endeavorortho.com
• Phone: 1-800-405-8862
• Email: info@endeavorortho.com
• Phone: 1-800-405-8862
• Email: info@endeavorortho.com
• Phone: 1-800-405-8862
• Email: info@endeavorortho.com
• Phone: 1-800-405-8862
• Email: info@endeavorortho.com
• Phone: 1-800-405-8862
• Email: info@endeavorortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860004838005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203408

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-11
• Device Publish Date: 2022-03-03

On-Brand Devices [Summit Patella Plating System]

• 00860004838012: Sterile, Single use, Patella Fracture Repair Kit, Small
• 00860004838005: Sterile, Single use, Patella Fracture Repair Kit, Standard