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510(k) K040889

Device
EXACTECH OPTETRAK UNICONDYLAR KNEE
Applicant
EXACTECH, INC.
510(k) number
K040889
Product code
HRY  
Decision
Substantially Equivalent (SESE)
Decision date
2004-10-01
Date received
2004-04-05
Regulation
888.3530
Classification name
Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
GARY MILLER
Address
2320 NW 66th Ct. Gainesville FL US 32653 32653

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HRY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UC2020-04-16
K190633NanoOrtho NanoKnee® SystemNanoortho, LLC2019-12-20
K152631MPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc.2016-03-23
K150410RESTORIS POROUS PARTIAL KNEE SYSTEMMako Surgical Corporation2015-03-20
K133940OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)Biomet UK, Ltd.2014-03-28
K131167UNIVATIONAesculap Implant Systems, LLC2013-10-17
K122277OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEMBiomet Manufacturing Corp2012-10-22
K110415SIGNATURE PLANNER / SIGNATURE GUIDESMaterialise NV2011-05-16
K100973EVOLUTION UNICONDYLAR KNEE SYSTEMWrightmedicaltechnologyinc2010-08-10
K082567STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSIONHowmedica Osteonics Corp.2008-10-03
K081293UNIVATION UNICONDYLAR KNEE SYSTEMAesculap Implant Systems, Inc.2008-09-22
K072704UNICOMPARTMENTAL KNEEValpo Orthopedic Technology, Inc.2008-02-19
K071881TRIATHLON PKR SYSTEMHowmedica Osteonics Corp.2007-10-09
K070267DEPUY GCK TIBIAL COMPONENTSDePuy Orthopaedics, Inc.2007-08-17
K063515TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEEBiomet Manufacturing, Inc.2007-02-02

Legacy Summary#

summary

FDA Review#

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