FDA.reportPublic FDA data

REMI Robotic Navigation System

Primary DI
00850026574166
Brand
REMI Robotic Navigation System
Company
Fusion Robotics, LLC
Model
1025
Device description
Awl
Published
2021-08-04
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202184000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202184000Practical Navigation Surgical Guidance System (PNSGS)Practical Navigation, LLC2021-02-24OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850026574166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850026574166008500265741668500265741660850026574166

GMDN Terms#

Term, Definition table
TermDefinition
Bone awlA spike-like, orthopaedic, surgical instrument that is used to bore holes in bone. It is typically designed as a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end. It is manually-operated by the surgeon who rotates the point back and forth on the bone whilst exerting pressure onto the handle. This operation will penetrate the hard outer bone and create a passage into, e.g., a medullary canal. It is typically made of high-grade stainless steel, titanium (Ti) and a synthetic material for the handle (e.g., Tufnol). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
117229400
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850026574661REMI Robotic Navigation System13452023-03-20
00850026574678REMI Robotic Navigation System13502023-03-20
00850026574685REMI Robotic Navigation System13552023-03-20
00850026574692REMI Robotic Navigation System13652023-03-20
00850026574708REMI Robotic Navigation System13752023-03-20
00850026574722REMI Robotic Navigation System13852023-03-20
00850026574555REMI Robotic Navigation System60252022-06-23
00850026574579REMI Robotic Navigation System60262022-06-23
00850026574715REMI Robotic Navigation System11022022-06-23
00850026574500REMI Robotic Navigation System106110612021-09-29
00850026574135REMI Robotic Navigation System10052021-08-04
00850026574142REMI Robotic Navigation System10102021-08-04
00850026574159REMI Robotic Navigation System10152021-08-04
00850026574173REMI Robotic Navigation System10262021-08-04
00850026574180REMI Robotic Navigation System10302021-08-04
00850026574197REMI Robotic Navigation System10352021-08-04
00850026574203REMI Robotic Navigation System10402021-08-04
00850026574210REMI Robotic Navigation System10452021-08-04
00850026574227REMI Robotic Navigation System10502021-08-04
00850026574234REMI Robotic Navigation System10602021-08-04

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