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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoulder Arthroplasty Implantation System
510(k) Number K202151
Device Name Smart SPACE Shoulder System
Applicant
TechMah Medical LLC
2099 Thunderhead Rd. Suite 302
Knoxville,  TN  37922
Applicant Contact Mohamed R. Mahfouz
Correspondent
Medical Device Academy, Inc.
345 Lincoln Hill Rd.
Shrewsbury,  VT  05738
Correspondent Contact Mary Vater
Regulation Number888.3660
Classification Product Code
QHE  
Subsequent Product Codes
KWS   MBF   OLO  
Date Received08/03/2020
Decision Date 02/03/2021
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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