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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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ROSA® Shoulder - 00887868558306

No Description
Orthosoft Inc
20-8087-700-00
In Commercial Distribution

  • 00887868558306 ()
20808770000

  • Robotic surgical navigation system application software

Mako - 07613327601008

No Description
MAKO SURGICAL CORP.
TKA 1.0.3 + THA 4.0.2 + PKA 3.0.4
In Commercial Distribution

  • 07613327601008 ()
700002149814

  • Robotic surgical navigation system application software

Mako - 07613327600070

No Description
MAKO SURGICAL CORP.
TKA 2.0.1+TKA 1.0.3+THA 4.1.1+PKA 3.0.4
In Commercial Distribution

  • 07613327600070 ()
700002150474

  • Robotic surgical navigation system application software

Mako - 07613327600063

No Description
MAKO SURGICAL CORP.
TKA 2.0.1+TKA 1.0.3+THA 4.0.2+PKA 3.0.4
In Commercial Distribution

  • 07613327600063 ()
700002150478

  • Robotic surgical navigation system application software

Mako - 07613327600001

No Description
MAKO SURGICAL CORP.
TKA 1.0.3+ THA 4.1.1 + PKA 3.0.4
In Commercial Distribution

  • 07613327600001 ()
700002145692

  • Robotic surgical navigation system application software

Mako - 07613327599985

No Description
MAKO SURGICAL CORP.
TKA 1.0.3 + THA 3.1.4 + PKA 3.0.4
In Commercial Distribution

  • 07613327599985 ()
700002149813

  • Robotic surgical navigation system application software

N/A - 07613327542998

Ortho Guidance Versatile Hip Sales Demo
Stryker Leibinger GmbH & Co. KG
81-80072
In Commercial Distribution

  • 07613327542998 ()
81-80072

  • Robotic surgical navigation system application software

N/A - 07613327542875

Ortho Guidance Versatile Hip Enable
Stryker Leibinger GmbH & Co. KG
6007-700-300
In Commercial Distribution

  • 07613327542875 ()
6007-700-300

  • Robotic surgical navigation system application software

N/A - 07613327542868

Ortho Guidance Versatile Hip Software
Stryker Leibinger GmbH & Co. KG
6007-700-000
In Commercial Distribution

  • 07613327542868 ()
6007-700-000

  • Robotic surgical navigation system application software

N/A - 07613327542370

Ortho Guidance Express Knee Sales Demo
Stryker Leibinger GmbH & Co. KG
81-80071
In Commercial Distribution

  • 07613327542370 ()
81-80071

  • Robotic surgical navigation system application software

N/A - 07613327542363

Ortho Guidance Express Knee Enable
Stryker Leibinger GmbH & Co. KG
6003-710-300
In Commercial Distribution

  • 07613327542363 ()
6003-710-300

  • Robotic surgical navigation system application software

N/A - 07613327542332

Ortho Guidance Express Knee Software
Stryker Leibinger GmbH & Co. KG
6003-710-000
In Commercial Distribution

  • 07613327542332 ()
6003-710-000

  • Robotic surgical navigation system application software

N/A - 07613327542219

Ortho Guidance Precision Knee Enable
Stryker Leibinger GmbH & Co. KG
6003-700-300
In Commercial Distribution

  • 07613327542219 ()
6003-700-300

  • Robotic surgical navigation system application software

N/A - 07613327542202

Ortho Guidance Precision Knee Sales Demo
Stryker Leibinger GmbH & Co. KG
81-80070
In Commercial Distribution

  • 07613327542202 ()
81-80070

  • Robotic surgical navigation system application software

N/A - 07613327541809

Ortho Guidance Precision Knee Software
Stryker Leibinger GmbH & Co. KG
6003-700-000
In Commercial Distribution

  • 07613327541809 ()
6003-700-000

  • Robotic surgical navigation system application software

PROFESS - 07613327286755

PROFESS(TM) SOFTWARE ENABLE
Stryker Leibinger GmbH & Co. KG
6001-400-300
In Commercial Distribution

  • 07613327286755 ()
6001-400-300

  • Robotic surgical navigation system application software

Mako - 07613327395341

No Description
MAKO SURGICAL CORP.
213951
In Commercial Distribution

  • 07613327395341 ()
213951

  • Robotic surgical navigation system application software

CRANIALMAP - 07613327004274

CRANIALMAP(TM) EXPRESS
Stryker Leibinger GmbH & Co. KG
6001-655-000
In Commercial Distribution

  • 07613327004274 ()
6001-655-000

  • Robotic surgical navigation system application software

ORTHOMAP - 07613327004250

VERSATILE HIP 2.0 SOFTWARE
Stryker Leibinger GmbH & Co. KG
6007-616-000
In Commercial Distribution

  • 07613327004250 ()
6007-616-000

  • Robotic surgical navigation system application software

FLUOROMAP - 07613252196259

FLUOROMAP 1.0 - SALES DEMO CD
Stryker Leibinger GmbH & Co. KG
81-81022
In Commercial Distribution

  • 07613252196259 ()
81-81022

  • Robotic surgical navigation system application software

ORTHOMAP - 07613252127444

ORTHOMAP¿ 3D 2.0 - SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-80049
In Commercial Distribution

  • 07613252127444 ()
81-80049

  • Robotic surgical navigation system application software

ORTHOMAP - 07613252127413

ORTHOMAP¿ 3D 2.0 - ENABLE
Stryker Leibinger GmbH & Co. KG
6005-660-300
In Commercial Distribution

  • 07613252127413 ()
6005-660-300

  • Robotic surgical navigation system application software

CRANIALMAP - 07613252510949

CRANIALMAP(TM) EXPRESS SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-81031
In Commercial Distribution

  • 07613252510949 ()
81-81031

  • Robotic surgical navigation system application software

CRANIALMAP - 07613252510932

CRANIALMAP(TM) NEURO SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-81030
In Commercial Distribution

  • 07613252510932 ()
81-81030

  • Robotic surgical navigation system application software

CRANIALMAP - 07613252510857

CRANIALMAP(TM) EXPRESS ENABLE
Stryker Leibinger GmbH & Co. KG
6001-655-300
In Commercial Distribution

  • 07613252510857 ()
6001-655-300

  • Robotic surgical navigation system application software

CRANIALMAP - 07613252510819

CRANIALMAP(TM) EXPRESS UPGRADE
Stryker Leibinger GmbH & Co. KG
6001-655-100
In Commercial Distribution

  • 07613252510819 ()
6001-655-100

  • Robotic surgical navigation system application software

CRANIALMAP - 07613252510802

CRANIALMAP(TM) EXPRESS SERVICE UPGRADE
Stryker Leibinger GmbH & Co. KG
6001-655-150
In Commercial Distribution

  • 07613252510802 ()
6001-655-150

  • Robotic surgical navigation system application software

CRANIALMAP - 07613252510710

CRANIALMAP(TM) NEURO ENABLE
Stryker Leibinger GmbH & Co. KG
6000-655-300
In Commercial Distribution

  • 07613252510710 ()
6000-655-300

  • Robotic surgical navigation system application software

CRANIALMAP - 07613252510703

CRANIALMAP(TM) NEURO SERVICE UPGRADE
Stryker Leibinger GmbH & Co. KG
6000-655-150
In Commercial Distribution

  • 07613252510703 ()
6000-655-150

  • Robotic surgical navigation system application software

CRANIALMAP - 07613252510673

CRANIALMAP(TM) NEURO UPGRADE
Stryker Leibinger GmbH & Co. KG
6000-655-100
In Commercial Distribution

  • 07613252510673 ()
6000-655-100

  • Robotic surgical navigation system application software

ORTHOMAP - 07613252450115

ORTHOMAP¿ VERSATILE HIP 2.0 ENABLE
Stryker Leibinger GmbH & Co. KG
6007-616-300
In Commercial Distribution

  • 07613252450115 ()
6007-616-300

  • Robotic surgical navigation system application software

ORTHOMAP - 07613252450108

ORTHOMAP¿ VERSATILE HIP 2.0 - UPGRADE
Stryker Leibinger GmbH & Co. KG
6007-616-100
In Commercial Distribution

  • 07613252450108 ()
6007-616-100

  • Robotic surgical navigation system application software

ORTHOMAP - 07613252449850

ORTHOMAP¿ VERSATILE HIP 2.0 SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-80056
In Commercial Distribution

  • 07613252449850 ()
81-80056

  • Robotic surgical navigation system application software

ORTHOMAP - 07613252449089

ORTHOMAP¿ PRECISION KNEE 5.0 SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-80055
In Commercial Distribution

  • 07613252449089 ()
81-80055

  • Robotic surgical navigation system application software

ORTHOMAP - 07613252448778

ORTHOMAP¿ PRECISION KNEE 5.0 - UPGRADE
Stryker Leibinger GmbH & Co. KG
6003-655-100
In Commercial Distribution

  • 07613252448778 ()
6003-655-100

  • Robotic surgical navigation system application software

ORTHOMAP - 07613252448761

ORTHOMAP¿ PRECISION KNEE 5.0 ENABLE
Stryker Leibinger GmbH & Co. KG
6003-655-300
In Commercial Distribution

  • 07613252448761 ()
6003-655-300

  • Robotic surgical navigation system application software

ORTHOMAP - 07613252433538

ORTHOMAP¿ EXPRESS KNEE 2.0 - ENABLE
Stryker Leibinger GmbH & Co. KG
6003-672-300
In Commercial Distribution

  • 07613252433538 ()
6003-672-300

  • Robotic surgical navigation system application software

ORTHOMAP - 07613252433521

ORTHOMAP¿ EXPRESS KNEE 2.0 - UPGRADE
Stryker Leibinger GmbH & Co. KG
6003-672-100
In Commercial Distribution

  • 07613252433521 ()
6003-672-100

  • Robotic surgical navigation system application software

ORTHOMAP - 07613252355717

ORTHOMAP¿ EXPRESS KNEE 2.0 - SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-80050
In Commercial Distribution

  • 07613252355717 ()
81-80050

  • Robotic surgical navigation system application software

FLUOROMAP - 07613252286622

FLUOROMAP 1.0 - ENABLE
Stryker Leibinger GmbH & Co. KG
6006-600-300
In Commercial Distribution

  • 07613252286622 ()
6006-600-300

  • Robotic surgical navigation system application software
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