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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K161426
Device Name NeoSpan Compression Staple Impant w/instruments
Applicant
In2bones USA, LLC
6060 Poplar Ave.
Suite 380
Memphis,  TN  38119
Applicant Contact JOE CLIFT
Correspondent
Enmed International, Inc.
P.O. Box 249
Del Mar,  CA  92014
Correspondent Contact LOUISE FOCHT
Regulation Number888.3030
Classification Product Code
JDR  
Date Received05/23/2016
Decision Date 10/24/2016
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
Recalls CDRH Recalls
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