FDA.reportPublic FDA data

510(k) K063515

Device
TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REPICCI II UNICONDYLAR KNEE
Applicant
BIOMET MANUFACTURING, INC.
510(k) number
K063515
Product code
HRY  
Decision
Substantially Equivalent (SESE)
Decision date
2007-02-02
Date received
2006-11-21
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
SUSAN ALEXANDER
Address
56 E Bell Dr. Warsaw IN US 46581 46581

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
K061681REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENTBiomet Manufacturing Corp2006-10-19

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases