FDA.reportPublic FDA data

Symani Surgical Robot Console Flat

Primary DI
08055713170535
Brand
Symani Surgical Robot Console Flat
Company
MEDICAL MICROINSTRUMENTS, INC.
Model
CNS-000
Device description
An assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a functional extension of the surgeon for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of an operator’s console and robotic arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities.
Published
2026-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
SAQElectromechanical System For Open Microsurgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SAQElectromechanical System For Open MicrosurgeryGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242368000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242368000Symani Surgical SystemMedical Microinstruments, Inc.2025-02-07SAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08055713170535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08055713170535080557131705358055713170535

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical telemanipulation systemAn assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a complete functional extension of the surgeon (master-stave telemanipulation) for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of an operator’s console and robotic arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities.

Regulatory Flags#

DUNS number
435958412
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08055713170191Symani Surgical Robot CMM Plug type "B"CMM-B0102026-07-20
08055713170528Symani Surgical Robot ConsoleCNS-1002026-07-20
08055713171112Symani NanoWrist Instruments Micro Needle HolderINS-AaT22212026-07-20
08055713171129Symani NanoWrist Instruments Micro Needle Holder Suture CutINS-AeT12212026-07-20
08055713171136Symani NanoWrist Instruments Micro DilatorINS-ObM12212026-07-20
08055713171143Symani NanoWrist Instruments SuperMicro Needle HolderINS-NaS22212026-07-20
08055713171150Symani NanoWrist Instruments SuperMicro DilatorINS-DbS12212026-07-20
08055713175042Symani Accessories Instrument ConnectorACC-1012026-07-20
08055713175059Symani Accessories Master ClipACC-2002026-07-20
08055713175066Symani Accessories Contoured Master ClipACC-2202026-07-20
08055713175073Symani Accessories Master HolderACC-3002026-07-20
08055713175011Symani Accessories Master ClipACC-2002025-04-21
08055713175028Symani Accessories Contoured Master ClipACC-2202025-04-21
08055713175035Symani Accessories Master HolderACC-3002025-04-21
08055713175004Symani Accessories Instrument ConnectorACC-1012025-04-21
08055713171082ScissorsINS-RfM32202026-03-06
08055713171099ForcepsINS-PbM12212026-03-06
08055713177046Synaptix Plug B TypeDWS-B1J000000W2026-03-06
08055713170146Symani Surgical Robot CMM Plug type "B"CMM-B0102025-04-21
08055713170504Symani Surgical Robot ConsoleCNS-1002025-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08055713170191Symani Surgical Robot CMM Plug type "B"MEDICAL MICROINSTRUMENTS, INC.SAQ2026-07-20
08055713170528Symani Surgical Robot ConsoleMEDICAL MICROINSTRUMENTS, INC.SAQ2026-07-20
08055713171112Symani NanoWrist Instruments Micro Needle HolderMEDICAL MICROINSTRUMENTS, INC.SAQ2026-07-20
08055713171129Symani NanoWrist Instruments Micro Needle Holder Suture CutMEDICAL MICROINSTRUMENTS, INC.SAQ2026-07-20
08055713171136Symani NanoWrist Instruments Micro DilatorMEDICAL MICROINSTRUMENTS, INC.SAQ2026-07-20
08055713171143Symani NanoWrist Instruments SuperMicro Needle HolderMEDICAL MICROINSTRUMENTS, INC.SAQ2026-07-20
08055713171150Symani NanoWrist Instruments SuperMicro DilatorMEDICAL MICROINSTRUMENTS, INC.SAQ2026-07-20
08055713175042Symani Accessories Instrument ConnectorMEDICAL MICROINSTRUMENTS, INC.SAQ2026-07-20
08055713175059Symani Accessories Master ClipMEDICAL MICROINSTRUMENTS, INC.SAQ2026-07-20
08055713175066Symani Accessories Contoured Master ClipMEDICAL MICROINSTRUMENTS, INC.SAQ2026-07-20
08055713175073Symani Accessories Master HolderMEDICAL MICROINSTRUMENTS, INC.SAQ2026-07-20
08055713171082ScissorsMEDICAL MICROINSTRUMENTS, INC.SAQ2026-03-06
08055713171099ForcepsMEDICAL MICROINSTRUMENTS, INC.SAQ2026-03-06
08055713177046Synaptix Plug B TypeMEDICAL MICROINSTRUMENTS, INC.SAQ2026-03-06
08055713175011Symani Accessories Master ClipMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713175028Symani Accessories Contoured Master ClipMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713175035Symani Accessories Master HolderMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713170146Symani Surgical Robot CMM Plug type "B"MEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713170504Symani Surgical Robot ConsoleMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713170511Symani Surgical Robot Console FlatMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713171020Symani NanoWrist Instruments Micro Needle HolderMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713171037Symani NanoWrist Instruments Micro Needle Holder Suture CutMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713171044Symani NanoWrist Instruments Micro DilatorMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713171051Symani NanoWrist Instruments SuperMicro Needle HolderMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713171068Symani NanoWrist Instruments SuperMicro DilatorMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713171075Symani NanoWrist Instruments SuperMicro Needle Holder Suture CutMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713175004Symani Accessories Instrument ConnectorMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
88055713175017Symani Accessories Master ClipMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
18055713175025Symani Accessories Contoured Master ClipMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
18055713175032Symani Accessories Master HolderMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21