MAVEN™ Patient-Specific Instrumentation

Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer

Paragon 28, Inc

The following data is part of a premarket notification filed by Paragon 28, Inc with the FDA for Maven™ Patient-specific Instrumentation.

Pre-market Notification Details

• Device ID: K223227
• 510k Number: K223227
• Device Name: MAVEN™ Patient-Specific Instrumentation
• Classification: Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
• Applicant: Paragon 28, Inc 14445 Grasslands Drive Englewood, CO 80112
• Contact: Greg Kowalczyk
• Correspondent: Jan Triani; Triani Consulting, LLC 14445 Grasslands Drive Englewood, CO 80112
• Product Code: HSN
• CFR Regulation Number: 888.3110 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-10-18
• Decision Date: 2022-11-17