FDA.reportPublic FDA data

Versius Surgeon Console

Primary DI
05060548211226
Brand
Versius Surgeon Console
Company
CMR SURGICAL LIMITED
Model
V-SS-1020
Published
2026-03-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
SCVModular Electromechanical Surgical System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SCVModular Electromechanical Surgical SystemGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252111000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252111000Versius Surgical System (Versius Plus)Cmr Surgical Limited2025-12-16SCV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060548211226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060548211226050605482112265060548211226

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical arm systemAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
219860797
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060548211349Versius Insulating Sleeve Accessory – Carton Pack (Qty 12 x 10021), 10022100222026-03-18
05060548211356Versius Insulating Sleeve Accessory Shipper Pack (Quantity 8 x 10022 in a shippe100232026-03-18
05060548210731Versius Endoscope 0° (vLimeLite)909102026-03-11
05060548211233Versius Instrument Bedside UnitV-SS-20202026-03-09
05060548211240Versius Visualisation Bedside UnitV-SS-30202026-03-09
05060548210229Versius Bedside Unit Cable (Short)90800/52026-03-10
05060548210366Versius Bedside Unit Cable (Long)90800/102026-03-10
05060548210526Versius Monopolar Instrument Cable905002026-03-10
05060548210724Versius Endoscope 30° (compatible with vLimeLite)909092026-03-10
05060548210748Versius Camera Head (compatible with vLimeLite)909112026-03-10
05060548210502Versius Bipolar Instrument Cable903002026-03-09
05060548210519Versius Bipolar Bedside Unit Cable904002026-03-09
05060548210533Versius Monopolar Bedside Unit Cable906002026-03-09
05060548211257Versius Needle Holder101202026-03-09
05060548211264Versius Bipolar Maryland Grasper102202026-03-09
05060548211271Versius Fenestrated Grasper103202026-03-09
05060548211288Versius Monopolar Hook104202026-03-09
05060548211295Versius Curved Scissors105202026-03-09
05060548211301Versius Monopolar Curved Scissors106202026-03-09
05060548211318Versius Insulating Sleeve Accessory100212026-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060548211349Versius Insulating Sleeve Accessory – Carton Pack (Qty 12 x 10021), 10022CMR SURGICAL LIMITEDSCV2026-03-18
05060548211356Versius Insulating Sleeve Accessory Shipper Pack (Quantity 8 x 10022 in a shippeCMR SURGICAL LIMITEDSCV2026-03-18
05060548210731Versius Endoscope 0° (vLimeLite)CMR SURGICAL LIMITEDSCV2026-03-11
05060548210229Versius Bedside Unit Cable (Short)CMR SURGICAL LIMITEDSCV2026-03-10
05060548210366Versius Bedside Unit Cable (Long)CMR SURGICAL LIMITEDSCV2026-03-10
05060548210526Versius Monopolar Instrument CableCMR SURGICAL LIMITEDSCV2026-03-10
05060548210724Versius Endoscope 30° (compatible with vLimeLite)CMR SURGICAL LIMITEDSCV2026-03-10
05060548210748Versius Camera Head (compatible with vLimeLite)CMR SURGICAL LIMITEDSCV2026-03-10
05060548210502Versius Bipolar Instrument CableCMR SURGICAL LIMITEDSCV2026-03-09
05060548210519Versius Bipolar Bedside Unit CableCMR SURGICAL LIMITEDSCV2026-03-09
05060548210533Versius Monopolar Bedside Unit CableCMR SURGICAL LIMITEDSCV2026-03-09
05060548211233Versius Instrument Bedside UnitCMR SURGICAL LIMITEDSCV2026-03-09
05060548211240Versius Visualisation Bedside UnitCMR SURGICAL LIMITEDSCV2026-03-09
05060548211257Versius Needle HolderCMR SURGICAL LIMITEDSCV2026-03-09
05060548211264Versius Bipolar Maryland GrasperCMR SURGICAL LIMITEDSCV2026-03-09
05060548211271Versius Fenestrated GrasperCMR SURGICAL LIMITEDSCV2026-03-09
05060548211288Versius Monopolar HookCMR SURGICAL LIMITEDSCV2026-03-09
05060548211295Versius Curved ScissorsCMR SURGICAL LIMITEDSCV2026-03-09
05060548211301Versius Monopolar Curved ScissorsCMR SURGICAL LIMITEDSCV2026-03-09
05060548211318Versius Insulating Sleeve AccessoryCMR SURGICAL LIMITEDSCV2026-03-09
05060548211325Versius Cadiere GrasperCMR SURGICAL LIMITEDSCV2026-03-09
05060548211332Versius Bipolar Fenestrated GrasperCMR SURGICAL LIMITEDSCV2026-03-09
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