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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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360CAS - B432360CAS01040

ASM Horseshoe Fixation
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0104
In Commercial Distribution

  • B432360CAS01040 ()


  • Robotic surgical navigation system application software

360CAS - B432360CAS01030

CAS General Instruments Tray
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0103
In Commercial Distribution

  • B432360CAS01030 ()


  • Robotic surgical navigation system application software

360CAS - B432360CAS01020

CAS Small Instruments Tray
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0102
In Commercial Distribution

  • B432360CAS01020 ()


  • Robotic surgical navigation system application software

360CAS - B432360CAS01000

ASM Cut Block
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0100
In Commercial Distribution

  • B432360CAS01000 ()


  • Robotic surgical navigation system application software

360CAS - B432360CAS00760

4mm Hex Driver Long
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0076
In Commercial Distribution

  • B432360CAS00760 ()


  • Robotic surgical navigation system application software

360CAS - B432360CAS00750

CAS Sterrad Instruments Tray
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0075
In Commercial Distribution

  • B432360CAS00750 ()


  • Robotic surgical navigation system application software

360CAS - B432360CAS00690

Bone Fixator
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0069
In Commercial Distribution

  • B432360CAS00690 ()


  • Robotic surgical navigation system application software

360CAS - B432360CAS00680

CAS Flex Driver
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0068
In Commercial Distribution

  • B432360CAS00680 ()


  • Robotic surgical navigation system application software

360CAS - B432360CAS00390

Tracker Universal Grip
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0039
In Commercial Distribution

  • B432360CAS00390 ()


  • Robotic surgical navigation system application software

360CAS - B432360CAS00280

UTC 2 Gimbal Stem
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0028
In Commercial Distribution

  • B432360CAS00280 ()


  • Robotic surgical navigation system application software

360CAS - B432360CAS00260

Gimbal Array Mount 90°
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0026
In Commercial Distribution

  • B432360CAS00260 ()


  • Robotic surgical navigation system application software

360CAS - B432360CAS00250

Gimbal Array Mount 0°
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0025
In Commercial Distribution

  • B432360CAS00250 ()


  • Robotic surgical navigation system application software

360CAS - B432360CAS00240

Pin Guide
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0024
In Commercial Distribution

  • B432360CAS00240 ()


  • Robotic surgical navigation system application software

360CAS - B432360CAS00130

CAS Pointer
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0013
In Commercial Distribution

  • B432360CAS00130 ()


  • Robotic surgical navigation system application software

360CAS - B432360CAS00100

Resection Guide Tool
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0010
In Commercial Distribution

  • B432360CAS00100 ()


  • Robotic surgical navigation system application software

360CAS - B432360CAS00040

Male Bone Fixator
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0004
In Commercial Distribution

  • B432360CAS00040 ()


  • Robotic surgical navigation system application software

360CAS - B432360CAS00030

Large CAS Tracker
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0003
In Commercial Distribution

  • B432360CAS00030 ()


  • Robotic surgical navigation system application software

360CAS - B432360CAS00020

Small CAS Tracker
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0002
In Commercial Distribution

  • B432360CAS00020 ()


  • 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

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

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

ROSA® Shoulder - 00887868558306

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

  • 00887868558306 ()
20808770000

  • Robotic surgical navigation system application software

PROFESS - 07613327071955

PROFESS(TM) SOFTWARE SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-81033
In Commercial Distribution

  • 07613327071955 ()
81-81033

  • Robotic surgical navigation system application software

PROFESS - 07613327071948

PROFESS(TM) SOFTWARE
Stryker Leibinger GmbH & Co. KG
6001-400-000
In Commercial Distribution

  • 07613327071948 ()
6001-400-000

  • Robotic surgical navigation system application software

SPINEMAP - 07613327114898

SPINEMAP¿ 3D 3.0 - SOFTWARE
Stryker Leibinger GmbH & Co. KG
6002-670-000
In Commercial Distribution

  • 07613327114898 ()
6002-670-000

  • Robotic surgical navigation system application software

SPINEMAP - 07613327115055

SPINEMAP¿ 3D 3.0 - SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-81000
In Commercial Distribution

  • 07613327115055 ()
81-81000

  • Robotic surgical navigation system application software

NA - 07613327115048

FLUOROSCOPY SOFTWARE 2.3 CD
Stryker Leibinger GmbH & Co. KG
81-80036
In Commercial Distribution

  • 07613327115048 ()
81-80036

  • Robotic surgical navigation system application software
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