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510(k) K133039

Device
RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM
Applicant
MAKO SURGICAL CORPORATION
510(k) number
K133039
Product code
NPJ  
Decision
Substantially Equivalent (SESE)
Decision date
2013-12-10
Date received
2013-09-26
Regulation
888.3560
Classification name
Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JONATHAN REEVES
Address
2555 Davie Rd. Fort Lauderdale FL US 33317 33317

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NPJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K150307RESTORIS Multicompartmental Knee SystemMako Surgical Corp.2015-03-10
K093513IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEMConformis, Inc.2009-12-16
K093056SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEMSmith & Nephew, Inc.2009-12-15
K090763RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEMMako Surgical Corporation2009-06-17
K070849DEPUY GCK FEMORAL AND TIBIAL COMPONENTSDePuy Orthopaedics, Inc.2007-06-26
K061648DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)DePuy Orthopaedics, Inc.2006-09-11
K061569SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTSSmith & Nephew, Inc.2006-07-06
K053488CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEMConformis, Inc.2006-03-09
K052265SMITH & NEPHEW COMPETITOR DUO KNEE FEMORALSmith & Nephew, Inc.2005-12-27
K052917STRYKER COMPARTMENTAL KNEE SYSTEMHowmedica Osteonics Corp.2005-12-27
K042896SMITH & NEPHEW HYBRID KNEE FEMORALSmith & Nephew, Inc.2005-01-12

Legacy Summary#

summary

FDA Review#

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