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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 K222078
Device Name Arthrex SoftStitch
Applicant
Arthrex, Inc
1370 Creekside Boulevard
Naples,  FL  34108 -1945
Applicant Contact Kelsey Roberts
Correspondent
Arthrex, Inc
1370 Creekside Boulevard
Naples,  FL  34108 -1945
Correspondent Contact Kelsey Roberts
Regulation Number878.5000
Classification Product Code
GAT  
Date Received07/14/2022
Decision Date 09/14/2022
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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