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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K203408
Device Name Summit Patella Plating System
Applicant
Endeavor Orthopaedics, LLC
11601 S Richmond Ave.
Tulsa,  OK  74137
Applicant Contact John Alleman
Correspondent
Allegiance Regulatory Consulting, LLC
16642 SW Lansford Ct.
Beaverton,  OR  97007
Correspondent Contact Alyssa Thomas
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
GAT  
Date Received11/19/2020
Decision Date 07/30/2021
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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