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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, nonabsorbable, synthetic, polyethylene
510(k) Number K170642
Device Name GRAVITY™ Soft Tissue Repair System
Applicant
Wright Medical Technology, Inc.
1023 Cherry Road
Memphis,  TN  38117
Applicant Contact Michael Mullins
Correspondent
Wright Medical Technology, Inc.
1023 Cherry Road
Memphis,  TN  38117
Correspondent Contact Michael Mullins
Regulation Number878.5000
Classification Product Code
GAT  
Subsequent Product Code
HWC  
Date Received03/02/2017
Decision Date 08/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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