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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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Femoral Paddle, Small Right A
CORIN LTD
TKR.BB.1700
In Commercial Distribution

  • 05056139244995 ()


  • Robotic surgical arm system
Dual Post Two Pin Universal Fixation
CORIN LTD
TKR.IN.1600
In Commercial Distribution

  • 05056139244971 ()


  • Robotic surgical arm system
Apollo BalanceBot Tibial Tray Trial Assembly - Large Right
CORIN LTD
TKR.BB.1402
In Commercial Distribution

  • 05056139244933 ()


  • Robotic surgical arm system
The intended use of the Micromate™ device is to function as a remote-operated positioning and guidance system during interventional procedures. Positioning is done in a remote-controlled manner; planning of the position/angulation is done based on 2D/3D patient data (CT, cone-beam CT, fluoroscopy) by external/internal planning software – for example using an image-guided navigation system or external/internal navigation system, or planning software coming with the used imaging device. Also, verification of the correct position and orientation of the tool prior to/during/after the intervention is done by means of these external devices. The Micromate™ system is then acting as a guideway during the manual insertion of the interventional tool – usually a needle type device, and the like - through a third-party needle guide, manufactured by Exact MM (K101689): P/N E2178 (Micromate Needle Guide Set, 8-11G), P/N E2183 (Micromate Needle Guide Set,10-14G) and P/N E2184 (Micromate Needle Guide Set, 15-21G). During operation, the device is covered with a sterile drape, which is part of the P/N2178, P/N E2183 and E2184. An additional third-party Control Unit Drape is available, also manufactured by Exact MM (K101689): P/N 11718EU (Micromate Control Unit Drape). Applications include, but are not limited to, interventions like biopsy procedures, tumor ablation, nerve blocking, electrode placement, etc.
iSYS Medizintechnik GmbH
iONE
In Commercial Distribution

  • 09010279000411 ()


  • Robotic surgical arm system
Surveillance Marker Holder
GLOBUS MEDICAL, INC.
6143.1934
In Commercial Distribution

  • 00193982192679 ()


  • Robotic surgical arm system
Cranial Dynamic Reference Base
GLOBUS MEDICAL, INC.
6143.1932
In Commercial Distribution

  • 00193982192655 ()


  • Robotic surgical arm system
Cranial Articulating Arm
GLOBUS MEDICAL, INC.
6143.1931
In Commercial Distribution

  • 00193982192648 ()


  • Robotic surgical arm system
CRW Frame Reference Array
GLOBUS MEDICAL, INC.
6143.1923
In Commercial Distribution

  • 00193982192617 ()


  • Robotic surgical arm system
Leksell Frame Reference Array
GLOBUS MEDICAL, INC.
6143.1921
In Commercial Distribution

  • 00193982192594 ()


  • Robotic surgical arm system
End Effector Guide Tube, 10.0mm
GLOBUS MEDICAL, INC.
6143.1780
In Commercial Distribution

  • 00193982192570 ()


  • Robotic surgical arm system
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