FDA.reportPublic FDA data

REMI Robotic Navigation System

Primary DI
00850026574685
Brand
REMI Robotic Navigation System
Company
Fusion Robotics, LLC
Model
1355
Device description
REMI 5.5 mm Cann. Dual Lead Tap
Published
2023-03-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
00850026574685PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850026574685008500265746858500265746850850026574685

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

Regulatory Flags#

DUNS number
117229400
Device count
1
Lot or batch
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
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
00850026574234REMI Robotic Navigation System10602021-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493426426RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426433RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426440RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426457RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426464RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426471RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426488RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426495RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426501RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426518RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426525RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426532RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426549RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426556RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426563RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426570RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426587RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426594RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426600RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426617RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426624RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426631RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00193982621940DURAPROGLOBUS MEDICAL, INC.OLO2026-08-14
00193982622039DURAPROGLOBUS MEDICAL, INC.OLO2026-08-14
00193982622091DURAPROGLOBUS MEDICAL, INC.OLO2026-08-14
00193982622114DURAPROGLOBUS MEDICAL, INC.OLO2026-08-14
00193982622138DURAPROGLOBUS MEDICAL, INC.OLO2026-08-14
00763000995195Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-08-14
00763000995218Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-08-14
00763000995232Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-08-14