Fusion Robotics Surgical Guidance System

GUDID 00850026574210

5.5mm Tap

Fusion Robotics, LLC

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Primary Device ID00850026574210
NIH Device Record Key648c8eb6-4097-49fb-bbfe-bab9a0f78ada
Commercial Distribution StatusIn Commercial Distribution
Brand NameFusion Robotics Surgical Guidance System
Version Model Number1045
Company DUNS117229400
Company NameFusion Robotics, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850026574210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


[00850026574210]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-12
Device Publish Date2021-08-04

On-Brand Devices [Fusion Robotics Surgical Guidance System]

00850026574364Spine System Software
00850026574357Camera Yoke
00850026574340Fusion Robotics Surgical Guidance System
00850026574333Camera Assembly
008500265742588mm Hex Driver, Reference Arm
00850026574241Reference Arm
00850026574234Driver
008500265742276.5mm Tap
008500265742105.5mm Tap
008500265742034.5mm Tap
00850026574197Slap Hammer
00850026574180Instrument Tracker
00850026574173Awl Tap Cap
00850026574166Awl
008500265741598mm Guide Sleeve
00850026574142Guide Tube with Tracker
00850026574135Registration Array

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