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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Toe, Hemi-, Phalangeal
510(k) Number K221220
Device Name Montross Extremity Medical Hemi Implant System
Applicant
Montross Extremity Medical
20 Belle Air Rd
Colorado Springs,  CO  80906
Applicant Contact William Montross
Correspondent
Intrepid Orthopedics, LLC
3953 Humphrey Road
Richfield,  OH  44286
Correspondent Contact Lee Strnad
Regulation Number888.3730
Classification Product Code
KWD  
Date Received04/27/2022
Decision Date 04/19/2023
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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