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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 K203634
Device Name BioPoly Great Toe Hemiarthroplasty Implant
Applicant
BioPoly, LLC
7136 Gettysburg Pike
Fort Wayne,  IN  46804
Applicant Contact Herb Schwartz
Correspondent
MCRA, LLC
1050 K. St. NW
Suite 1000
Washington,  DC  20001
Correspondent Contact Dave McGurl
Regulation Number888.3730
Classification Product Code
KWD  
Date Received12/11/2020
Decision Date 02/02/2021
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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