MAKO SURGICAL CORP.

FDA Device Registration & Listing · Weston, FL, US · Registration 3017410889

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3017410889
FEI Number
3005985723
Entity Name
MAKO SURGICAL CORP.
City/State/Country
Weston, FL, US
Establishment Address
3365 ENTERPRISE AVE, Weston, FL 33331, US
Establishment Type(s)
Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
STRYKER CORP. (Owner Number: 1811755)
Owner / Operator Contact Address
4100 East Milham Ave., Kalamazoo, MI 49001, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

RAVINE Access System Trays CANYON Retractor Systems Trays EVEREST Spinal System Trays Triathlon System Instrument trays Navigated Spine Instruments Trays DENALI Spinal System Trays CHESAPEAKE Stabilization System Trays Cascadia Interbody System Navigation Instruments Trays Stryker Orthopaedics Instrument Trays YUKON OCT Spinal System Trays PYRENEES Cervical Plate System Trays NAPA Access System Tornier Q Pedicle Instruments Aequalis Reversed II Eikon LT Sterilization Tray CAYMAN Plate System Trays Tornier Perform Anatomic Glenoid Aequalis Fracture Aequalis Reversed Fracture CASPIAN Spinal System Trays ATP Disc Prep Pangea Platform CAPRI Corpectomy Cage System Trays INBONE Eikon LT SL Sterilization Tray MESA Spinal System Trays Restoration Modular Instrument Trays ALEUTIAN Interbody Systems Trays OZARK Cervical Plate System Trays Tornier Pyrocarbon Aluminum Lid - Universal Triathlon MSI Tray SAHARA Stabilization System Trays Sterilization Box, Lightweight Hoffmann LRF Tornier Flex Shoulder System Universal Neuro III Accessory Tray Mako Instrument Trays Hybrid Tip Pointer Mako Total Knee Application 3 Mako TKA Mako Total Hip Application MAKO Unicondylar Knee System Restoris MCK Impactors Drill Guides Restoris MCK Manual Instrument Kit Restoris MCK Patella Resection Clamps Restoris MCK Onlay Insert Trials, Caddys Restoris MCK Uni Instrument Set, Caddys Restoris MCK Instrument Kit, Inlay and Onlay Instruments Restoris MCK Instrument Kit, PF Instruments Restoris MCK Instrument Set, Caddys Mako Total Knee Application Mako Total Hip Application Mako Partial Knee Application MAKO Unicondylar Knee System Stryker Leg Holder General Instruments Triathlon Leg Positioner Disposables SofCare Heel Care Boot Restoris Porous Partial Knee System MAKO Compartmental Knee System RIO THA System Mako Total Knee Application Restoris MCK X3 Unicondylar Tibial Insert Restoris MCK Femoral Component Restoris MCK Patella Resurfacing Round Dome Restoris MCK X3 Tibial Onlay Insert Restoris MCK Tibial Baseplate Restoris MCK Patellofemoral Component Restoris MCK Tibial Onlay Insert Mako TKA System Mako Total Hip Application Restoris MCK Knee System Triathlon PKR System Triathlon Knee System Restoris MCK X3 Unicondylar Tibial Insert Triathlon PKR Triathlon Total Knee System Restoris MCK Mako Total Knee Application Calibration End Effector, Inverted Stryker Leg Positioner SPYPHI ARTICULATING ARM MAIN ARM SPYPHI ARTICULATING ARM TABLE CLAMP SPYPHI ARTICULATING ARM IMAGING HEAD HOLDER Eiberg Retractor, Standard Eikon LT Adapt, 90 mm, Wide Eikon LT Retractor, 135 mm, Narrow Invuity Breisky 170mm Eikon LT Retractor, A-N, 35 mm & 50 mm Eikon LT Fixed Frame Retractor, 90mm Wide Eval Eikon LT Retractor, 40 mm, Narrow Invuity St. Marks 11 in Retractor Glenoid Retractor Eikon LT Retractor, 135 mm, Sweetheart Eikon LT Retractor, 90 mm, Narrow Eikon LT Retractor, 50 mm Eikon LT Fixed Frame Retractor, 135mm Wide Eval Eikon LT Retractor, 135 mm, Wide Eikon LT Retractor, 90 mm Eikon LT Adapt Smoke Evacuation 135mm, Teeth Retractor Eikon LT Retractor, Rich, 60mm x 45mm Eikon LT Retractor, 90 mm, Wide Eikon LT Adapt Smoke Evacuation 135mm, Wide Retractor Eiberg Retractor, Standard, Long Eikon LT Adapt, 135 mm, Wide, Teeth Reusable Slat for Eikon LT Adapt Smoke Evacuation 175mm Retractor, 10 Pack Reusable Slat for Eikon LT Adapt Smoke Evacuation 135 mm Retractor, 10 Pack Eikon LT Adapt Smoke Evacuation 135mm Retractor Eikon LT Adapt Smoke Evacuation 90mm Retractor Eikon LT Adapt Smoke Evacuation 175mm, Wide Retractor Eikon LT Retractor, 40 mm, Extra Narrow Eikon LT Retractor, Rich, 40mm x 38mm Eikon LT Adapt Smoke Evacuation 90mm, Wide Retractor Eikon LT Retractor, 175 mm Eikon LT Adapt Smoke Evacuation 175mm, Wide, Teeth Retractor Eikon LT Retractor, 90 mm, Teeth Eikon LT Adapt, 175 mm Invuity A-N, 35mm & 50mm Extra Narrow Retractor Invuity Deaver 25mm Wide Retractor Eikon LT Adapt Smoke Evacuation 175mm, Teeth Retractor Invuity A-N, 35mm & 50mm Narrow Retractor Eikon LT Retractor, 90 mm, Narrow Teeth Eikon LT Adapt, 135 mm, Teeth Eikon LT Adapt Smoke Evacuation 155mm, Teeth Retractor Invuity Deaver 38mm Wide Retractor Invuity Breisky 130mm Eikon LT Adapt, 90 mm, Wide, Teeth Reusable Slat for Eikon LT Adapt Smoke Evacuation 155mm Retractor, 10 Pack Eikon LT Retractor, 90 mm, Wide, Teeth Eikon LT Fixed Frame Retractor, 135mm Eval Eikon LT Retractor, 175 mm, Teeth Eikon LT Adapt, 135 mm Eikon LT Adapt, 90 mm Eikon LT Adapt Smoke Evacuation 90mm, Teeth Retractor Eikon LT Adapt Smoke Evacuation 135mm, Wide, Teeth Retractor Eikon LT Adapt Smoke Evacuation 175mm Retractor Eikon LT Retractor, 135 mm, Teeth Eikon LT Fixed Frame Retractor, 90mm Eval Eikon LT Adapt, 135 mm, Wide Eikon LT Retractor, 135 mm, Wide, Teeth Eikon LT Adapt Smoke Evacuation 155mm, Wide, Teeth Retractor Eikon LT Retractor, 50 mm, Teeth Eikon LT Retractor, 135 mm, Narrow Teeth Eikon LT Adapt, 90 mm, Teeth Invuity St. Marks 9 in Retractor Eikon LT Adapt, 175 mm, Teeth Reusable Slat for Eikon LT Adapt Smoke Evacuation 90mm Retractor, 10 Pack Eikon LT Retractor, Rich, 80mm x 60mm Eikon LT Retractor, 135 mm Retractor Eikon LT Adapt Smoke Evacuation 155mm, Wide Retractor Eikon LT Adapt Smoke Evacuation 90mm, Wide, Teeth Retractor Eikon LT Adapt Smoke Evacuation 155mm Retractor Aequalis" Instrument Aequalis" Retractor Shoulder System HLS NOETOS AEQUALIS RESURFACING HEAD HLS UNI EVOLUTION AEQUALIS REVERSED RETRACTOR Tornier Approach Eikon LT Adapt SE 155 mm, Wide Retractor Eikon LT Adapt SE 135mm, Teeth Retractor Eikon LT FF 135mm Retractor Eikon LT FF 90mm Retractor Eikon LT Adapt SE 175 mm, Wide Retractor Eikon LT Adapt SE 90mm, Teeth Retractor 135 mm Reusable Slat, SE Retr, 10 Pack 90 mm Reusable Slat, SE Retr, 10 Pack Eikon LT Adapt SE 135mm Retractor Eikon LT Adapt SE 155 mm,Wide,Teeth Retr Eikon LT Adapt SE 175mm Retractor Eikon LT Adapt SE 155mm, Teeth Retractor 175mm Reusable Slat, SE Retr, 10 Pack Eikon LT Adapt SE 155mm Retractor St. Mark’s 9 in. Retractor St. Mark’s 11 in. Retractor Eikon LT FF 175mm Retractor Eikon LT FF 135mm, Wide Retractor Eikon LT Adapt SE 90 mm, Wide Teeth Retr Eikon LT Adapt SE 90mm Retractor Eikon LT FF Replacement Screw Invuity A-N, 35mm & 50mm Narrow Retracto 155 mm Reusable Slat, SE Retr, 10 Pack Invuity A-N, 35mm & 50mm Extra Narrow Re Eikon LT Adapt SE 175 mm,Wide,Teeth Retr Eikon LT Adapt SE 135 mm, Wide Retractor Eikon LT Adapt SE 175mm, Teeth Retractor Eikon LT FF 90mm, Wide Retractor Eikon LT Adapt SE 90 mm, Wide Retractor Mako Partial Knee

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 1992-12-29
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-05-19
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2017-10-20
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2017-06-15
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2014-12-09
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2014-12-09
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2014-12-09
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2014-12-09
NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2014-12-09
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2020-12-14
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-03-27
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2017-06-15
NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2018-11-05
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2018-11-05
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2018-11-05
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2014-12-09
FQM Bandage, Elastic General Hospital Class 1 880.5075 2016-06-16
HXC Wrench Orthopedic Class 1 888.4540 1992-11-23
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-08-29
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 1977-12-29
NJD Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer Orthopedic Class 2 888.3535 2014-12-15
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2014-12-15
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2014-12-09
NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2014-12-09
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2014-12-09
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2014-12-09
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2015-12-15
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2019-12-04
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2015-05-14
NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2015-05-14
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2015-05-14
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2015-05-14
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2015-05-14
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2022-09-13
NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2022-09-13
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2022-09-13
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2022-09-13
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2015-08-07
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2020-02-05
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2025-02-28
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2025-02-28
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2025-02-28
NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2025-02-28
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2025-02-28
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2025-02-28
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2014-12-09
NJD Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer Orthopedic Class 2 888.3535 2015-08-07
OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic Class 2 888.3560 2015-08-07
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2015-08-07
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2017-11-03
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic Class 2 888.3565 2017-11-03
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2017-11-03
NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2017-11-03
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2017-11-03
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2017-11-03
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2014-12-09
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-05-17
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-09-05
FWZ Operating Room Accessories Table Tray General, Plastic Surgery Class 1 878.4950 1989-09-27
GAD Retractor General, Plastic Surgery Class 1 878.4800 2007-04-05
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2017-11-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STRYKER CORP.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3003897776 BIOMIMETIC THERAPEUTICS,LLC FRANKLIN, TN, US
3040801290 Inari Medical, Costa Rica S.A. Grecia Alajuela, CR
2031049 TMJ Solutions, LLC San Buenaventura, CA, US
3016573902 Ortho-Space Ltd. Caesarea Haifa, IL
3010411911 POM Medical, LLC Moorpark, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K260601 Blue Belt Technologies, Inc. REAL INTELLIGENCE™ CORI™ 2026-03-26
K033769 Howmedica Osteonics Corp. EIUS UNICOMPARTMENTAL KNEE SYSTEM 2004-02-13
K771511 3M Company TOTAL KNEE PROSTHESIS-NONCONSTRAINED 1977-11-30
K780299 Richard'S Medical Equip., Inc. TOTAL KNEE SYSTEM 1978-04-27
K901338 Kirschner Medical Corp. KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM 1990-05-22

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2016 Zimmer, Inc. 1
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0041-2024 Blue Belt Technologies, Inc 2
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0009-2008 N/A 2
EPIK KNEE SYSTEM Angled Insert Impactor LM/RL; Catalog #801-03-051 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
Z-0020-2022 Exactech, Inc. 2
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Z-0001-2019 Smith & Nephew, Inc. 2
Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017410889. Last updated year: 2026. Please use registration number 3017410889 when referencing this establishment in official correspondence.
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