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510(k) K203855

Device
CoNextions TR Tendon Repair System
Applicant
CoNextions Medical
510(k) number
K203855
Product code
GAQ  
Decision
Substantially Equivalent (SESE)
Decision date
2022-04-22
Date received
2020-12-31
Regulation
878.4495
Classification name
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Matthew Swift
Address
150 N. Wright Brothers Dr., Suite 560 Salt Lake City UT US 84116 84116

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GAQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K193209Wego-Stainless SteelFoosin Medical Supplies Inc., Ltd.2020-02-19
K172146MERISTEELM/s. Meril Endo Surgery Private Limited.2018-02-01
K170767Surgical Stainless Steel Suture, Stainless Steel SutureETHICON, Inc.2017-11-01
K141007DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTUREDemetech Corp.2014-09-25
K140127FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMPPontis Orthopaedics, LLC2014-05-28
K081060FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5Core Essence Orthopaedics, LLC2008-12-24
K082828SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICESuturtek Incorporated2008-10-14
K063603SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17Suturtek Incorporated2007-02-07
K042606MODIFICATION TO:SYNTHES (USA) TITANIUM WIRESynthes (Usa)2005-05-27
K041333SYNTHES (USA) TITANIUM WIRESynthes (Usa)2004-08-27
K032468SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICESuturtek Incorporated2003-09-23
K023594TENO FIXOrtheon Medical, LLC2003-05-15
K030351STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLECp Medical2003-03-28
K023411STEELEX STERNUM SETAesculap, Inc.2002-12-19
K022777MANUAL TOUCHE SYSTEMOnux Medical, Inc.2002-11-19

Legacy Summary#

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FDA Review#

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