FDA.reportPublic FDA data

REMI Robotic Navigation System

Primary DI
00850026574241
Brand
REMI Robotic Navigation System
Company
Fusion Robotics, LLC
Model
1065
Device description
Reference Arm
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
00850026574241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850026574241008500265742418500265742410850026574241

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical navigation systemAn assembly of electromechanical devices used during orthopaedic computer assisted surgery (CAS) as a functional extension of the surgeon for precise procedural movement and placement (navigation) during the procedure (e.g., placement of a pedicle screw in spinal surgery). It is computer-based and typically consists of, e.g., an operator's console and a video camera used to track the instrumentation. The input to the computer is usually by means of an existing CT or MRI scan that is used as a template. The system tracks the instrumentation by reading the location points giving a three-dimensional (3-D) picture of the instrument's position/angulation. It can also be used as a training aid.

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
00850026574166REMI Robotic Navigation System10252021-08-04
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

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Primary DI, Brand, Company table
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00840493422831RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
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00840493422855RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422862RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422879RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422886RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05