Fusion Robotics Surgical Guidance System

GUDID 00850026574340

Fusion Robotics Surgical Guidance System

Fusion Robotics, LLC

Robotic surgical navigation system

Primary Device ID	00850026574340
NIH Device Record Key	22df7c3b-07e3-43b8-8b2a-94e4ea5c79bf
Commercial Distribution Status	In Commercial Distribution
Brand Name	Fusion Robotics Surgical Guidance System
Version Model Number	PN-001
Company DUNS	117229400
Company Name	Fusion Robotics, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850026574340 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K202184

FDA Product Code

OLO	Orthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

[00850026574340]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-08-12
Device Publish Date	2021-08-04

On-Brand Devices [Fusion Robotics Surgical Guidance System]

00850026574364	Spine System Software
00850026574357	Camera Yoke
00850026574340	Fusion Robotics Surgical Guidance System
00850026574333	Camera Assembly
00850026574258	8mm Hex Driver, Reference Arm
00850026574241	Reference Arm
00850026574234	Driver
00850026574227	6.5mm Tap
00850026574210	5.5mm Tap
00850026574203	4.5mm Tap
00850026574197	Slap Hammer
00850026574180	Instrument Tracker
00850026574173	Awl Tap Cap
00850026574166	Awl
00850026574159	8mm Guide Sleeve
00850026574142	Guide Tube with Tracker
00850026574135	Registration Array

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