Baby Gorilla®/Gorilla® Plating System

Plate, Fixation, Bone

Paragon 28, Inc.

The following data is part of a premarket notification filed by Paragon 28, Inc. with the FDA for Baby Gorilla®/gorilla® Plating System.

Pre-market Notification Details

• Device ID: K222194
• 510k Number: K222194
• Device Name: Baby Gorilla®/Gorilla® Plating System
• Classification: Plate, Fixation, Bone
• Applicant: Paragon 28, Inc. 14445 Grasslands Drive Englewood, CO 80112
• Contact: Haylie Hertz
• Correspondent: Haylie Hertz; Paragon 28, Inc. 14445 Grasslands Drive Englewood, CO 80112
• Product Code: HRS
• Subsequent Product Code: HTN
• Subsequent Product Code: HWC
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-07-22
• Decision Date: 2022-08-19