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 A

Fastener, Fixation, Nondegradable, Soft Tissue

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for 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 A.

Pre-market Notification Details

Device IDK152566
510k NumberK152566
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 A
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant SMITH & NEPHEW, INC. 130 FORBES BOULEVARD Mansfield,  MA  02048
ContactKatherine Marcaccio
CorrespondentKatherine Marcaccio
SMITH & NEPHEW, INC. 130 FORBES BOULEVARD Mansfield,  MA  02048
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-09
Decision Date2015-12-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00885556885338 K152566 000
03596010577993 K152566 000
03596010578914 K152566 000
03596010578921 K152566 000
03596010581631 K152566 000
03596010581648 K152566 000
03596010584458 K152566 000
03596010584472 K152566 000
03596010584489 K152566 000
00885556885314 K152566 000
00885556885321 K152566 000
03596010577986 K152566 000

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