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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoulder Prosthesis, Reverse Configuration
510(k) Number K211553
Device Name Tecomet Global Unite Short Stem Instrumentation
Applicant
Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc.
3724 N. State Rd. 15
Warsaw,  IN  46582
Applicant Contact Mike Parrish
Correspondent
Fdc Services, LLC
8708 Capehart Cove
Austin,  TX  78733
Correspondent Contact David Furr
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
HSD   KWS  
Date Received05/19/2021
Decision Date 08/04/2021
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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