FDA.reportPublic FDA data

MAKO SURGICAL CORP.

Matched from indexed company URL: MAKO Surgical Corp.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30174108893005985723MAKO SURGICAL CORP.1Y2026-01-013365 ENTERPRISE AVE Weston FL US 33331
30059857233005985723MAKO SURGICAL CORP.1N2020-04-252555 Davie Road Fort Lauderdale FL US 33317

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2809081598428800K260222Mako Total Knee ApplicationOLO2026-02-25
2809081435576171K250608Mako Total Knee Application (3.0); Hybrid Tip PointerOLO2025-04-25
2809081797326529K243751Mako Total Hip Application 5.0OLO2025-03-05
2809082031208299K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee SystemJWH2024-12-04
2809081306644220K242373Mako Shoulder Application (1.0)OLO2024-11-07
2809081936087384K241517Q Guidance System; Mako Spine System;OLO2024-08-27
2809081364835216K241011Mako Total Knee ApplicationOLO2024-06-11
2809082007490801K220930Restoris Multi-Compartmental Knee SystemHSX2022-06-02
2809081140779961K220459Mako Total Knee ApplicationOLO2022-04-15
2809081835680537K193515Mako Total Knee ApplicationOLO2020-07-14
2809081290722185K193128Mako Total Hip ApplicationOLO2020-02-02
1776701290722185K193128Mako Total Hip ApplicationOLO2020-02-02
1776701509530656K191998Mako Total Hip Application, Mako Total Knee ApplicationOLO2019-09-24
2809081509530656K191998Mako Total Hip Application, Mako Total Knee ApplicationOLO2019-09-24
2809081357445169K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial InsertsHSX2018-06-07
1776701357445169K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial InsertsHSX2018-06-07
1776701446842265K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemJWH2017-10-30
2809081446842265K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemJWH2017-10-30
1776701089843663K172301Mako Partial Knee ApplicationOLO2017-11-02
2809081089843663K172301Mako Partial Knee ApplicationOLO2017-11-02
2809081348066339K172219Mako Total Knee ApplicationOLO2017-09-21
1776701348066339K172219Mako Total Knee ApplicationOLO2017-09-21
2809081535290398K170891Mako Partial Knee ApplicationOLO2017-05-24
1776701535290398K170891Mako Partial Knee ApplicationOLO2017-05-24
1776701872264465K170593Mako Total Hip ApplicationOLO2017-04-18
2809081872264465K170593Mako Total Hip ApplicationOLO2017-04-18
2809081020568164K170584Mako Partial Knee ApplicationOLO2017-05-11
1776701020568164K170584Mako Partial Knee ApplicationOLO2017-05-11
1776701040382137K170581Mako Total Knee ApplicationOLO2017-05-11
2809081040382137K170581Mako Total Knee ApplicationOLO2017-05-11
2809081571461438K150410RESTORIS POROUS PARTIAL KNEE SYSTEMHRY2015-03-20
1776701571461438K150410RESTORIS POROUS PARTIAL KNEE SYSTEMHRY2015-03-20
2809081662759258K150307RESTORIS Multicompartmental Knee SystemNPJ2015-03-10
1776701662759258K150307RESTORIS Multicompartmental Knee SystemNPJ2015-03-10
1776701551746453K143752Total Knee Application (TKA)OLO2015-08-06
2809081551746453K143752Total Knee Application (TKA)OLO2015-08-06
1776701512580220K143635KINETIS Total Knee SystemJWH2015-02-20
1776701437776403K142606Trident® Tritanium® PST® Acetabular ShellsLPH2015-01-26
2809081437776403K142606Trident® Tritanium® PST® Acetabular ShellsLPH2015-01-26
1776701870395189K142530Partial Knee Application (PKA)OLO2015-09-16
2809081870395189K142530Partial Knee Application (PKA)OLO2015-09-16
1776701796622271K141989MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEMOLO2014-11-13
2809081796622271K141989MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEMOLO2014-11-13
1776701086320475K133811RESTORIS POROUS PARTIAL KNEE SYSTEMNJD2014-07-08
2809081086320475K133811RESTORIS POROUS PARTIAL KNEE SYSTEMNJD2014-07-08
1776701545051190K133039RESTORIS MULTICOMPARTMENTAL KNEE SYSTEMNPJ2013-12-10
2809081545051190K133039RESTORIS MULTICOMPARTMENTAL KNEE SYSTEMNPJ2013-12-10
1776701738243026K132046PIPELINE KNEE SYSTEMJWH2013-09-23
1776702064910424K131237PIPELINE TOTAL HIP SYSTEMLPH2013-06-13
1776701753080258K130353PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)LPH2013-07-01
1776701528033738K123692PIPELINE KNEE SYSTEMJWH2013-05-24
1776701896468462K122158PBP TOTAL HIP SYSTEMOQG2012-12-11
1776701273660550K121064MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEMOLO2012-06-06
2809081273660550K121064MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEMOLO2012-06-06
1776701579530782K112802PIPELINE TOTAL HIP SYSTEMOQG2012-03-09
1776701322190182K112507RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEMOLO2012-03-01
2809081322190182K112507RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEMOLO2012-03-01
1776702007834152K093425MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THAOLO2010-02-24
2809081103615048K090763RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEMNPJ2009-06-17
1776701103615048K090763RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEMNPJ2009-06-17
2809081509332691K082172MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEMHSX2008-11-28
1776701509332691K082172MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEMHSX2008-11-28
1776701992521242K081867MAKO SURGICAL TACTILE GUIDANCE SYSTEM VERSION 2.0HAW2008-11-25
2809081900639846K073248MODIFICATION TO:MAKO SURGICAL UNICONDYLAR KNEE SYSTEMHSX2007-12-12
1776701900639846K073248MODIFICATION TO:MAKO SURGICAL UNICONDYLAR KNEE SYSTEMHSX2007-12-12
1776702069773811K060017MAKO SURGICAL UNICONDYLAR KNEE SYSTEMHSX2006-02-23
2809082069773811K060017MAKO SURGICAL UNICONDYLAR KNEE SYSTEMHSX2006-02-23
1776701079907762
1776701154504975
1776701193589410
1776701244950414
1776701306061146
1776701406486892
1776701426390856
1776701730830736
1776701818764156
1776701860049516
1776701988159059
2809081079907762
2809081154504975
2809081193589410
2809081244950414
2809081306061146
2809081406486892
2809081426390856
2809081730830736
2809081818764156
2809081860049516

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OLO352026-02-25
HSX92022-06-02
JWH62024-12-04
NPJ62015-03-10
LPH42015-01-26
HRY22015-03-20
NJD22014-07-08
OQG22012-12-11
HAW12008-11-25

PMN#

41 records. Showing 1-40. Next

GUDID#

200 records. Showing 1-40. Next