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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name fastener, fixation, nondegradable, soft tissue
510(k) Number K152566
Device Name PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTO
Applicant
SMITH & NEPHEW, INC.
130 FORBES BOULEVARD
MANSFIELD,  MA  02048
Applicant Contact KATHERINE MARCACCIO
Correspondent
SMITH & NEPHEW, INC.
130 FORBES BOULEVARD
MANSFIELD,  MA  02048
Correspondent Contact KATHERINE MARCACCIO
Regulation Number888.3040
Classification Product Code
MBI  
Date Received09/09/2015
Decision Date 12/02/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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