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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, toe, constrained, polymer
510(k) Number K153609
Device Name RTS Flexible 1 MPJ Implant w/Grommets
Applicant
In2BonesUSA, LLC
6060 Poplar Ave, Suite 380
Mephis,  TN  38119
Applicant Contact Joe Clift
Correspondent
ENMED International, Inc
PO Box 249
Del Mar,  CA  92014
Correspondent Contact Louise Focht
Regulation Number888.3720
Classification Product Code
KWH  
Date Received12/17/2015
Decision Date 09/08/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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