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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 K133770
Device Name A.I.M. KNOTLESS MENISCAL REPAIR DEVICE
Applicant
Anchor Innovation Medical (A.I.M.)
5410 Edson Ln., Suite 308
Rockville,  MD  20852
Applicant Contact KAREN M BECKER, PH.D.
Correspondent
Anchor Innovation Medical (A.I.M.)
5410 Edson Ln., Suite 308
Rockville,  MD  20852
Correspondent Contact KAREN M BECKER, PH.D.
Regulation Number878.5000
Classification Product Code
GAT  
Date Received12/11/2013
Decision Date 06/10/2014
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
Predetermined Change
Control Plan Authorized		 No
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