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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(k) Number K241597
Device Name Freedom® Total Knee System - Porous Tibial Base Plate
Applicant
Maxx Orthopedics, Inc.
2460 General Armistead Ave. Suite 100
Norristown,  PA  19403
Applicant Contact Corey Perine
Correspondent
Secure BioMed Evaluations
7828 Hickory Flat Hwy Suite 120
Woodstock,  GA  30188
Correspondent Contact Justin Gracyalny
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Code
JWH  
Date Received06/03/2024
Decision Date 02/13/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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