FDA.reportPublic FDA data

SIros-X

Primary DI
M719GSIX117L0
Brand
SIros-X
Company
Genesys Orthopedics Systems LLC
Model
1
Catalog number
GSI-X117-L
Device description
SIros-X Counter Torque, Long
Published
2026-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System
OLOOrthopedic Stereotaxic Instrument
OURSacroiliac Joint Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2
OLOOrthopedic Stereotaxic InstrumentNeurology2
OURSacroiliac Joint FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252322000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252322000SIros-X SystemGenesys Spine2025-10-22OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M719GSIX117L0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic counter-torque/rod-pushing instrumentA hand-held, manual, tube-like surgical instrument with a right-angled handle designed to apply a rotational force that opposes the directional force of torque when tightening (locking) a screw or screw head setscrew with a screwdriver, inserted down the instrument's hollow centre, during orthopaedic surgery. In addition, it may be used to push (seat) an orthopaedic rod into the slotted screw heads of screws that have been inserted into bone (e.g., vertebrae). It is typically made of high-grade stainless steel or titanium alloy, and synthetic materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
5123817070info@genesysspine.com

Regulatory Flags#

DUNS number
017921066
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M719GAC301050Stasys-C Standalone1GAC301-052026-04-01
M719GAC301060Stasys-C Standalone1GAC301-062026-04-01
M719GAC301070Stasys-C Standalone1GAC301-072026-04-01
M719GAC301080Stasys-C Standalone1GAC301-082026-04-01
M719GAC301090Stasys-C Standalone1GAC301-092026-04-01
M719GAC301100Stasys-C Standalone1GAC301-102026-04-01
M719GAC301110Stasys-C Standalone1GAC301-112026-04-01
M719GAC301120Stasys-C Standalone1GAC301-122026-04-01
M719GAC302050Stasys-C Standalone1GAC302-052026-04-01
M719GAC302060Stasys-C Standalone1GAC302-062026-04-01
M719GAC302070Stasys-C Standalone1GAC302-072026-04-01
M719GAC302080Stasys-C Standalone1GAC302-082026-04-01
M719GAC302090Stasys-C Standalone1GAC302-092026-04-01
M719GAC302100Stasys-C Standalone1GAC302-102026-04-01
M719GAC302110Stasys-C Standalone1GAC302-112026-04-01
M719GAC302120Stasys-C Standalone1GAC302-122026-04-01
M719GAC303060Stasys-C Standalone1GAC303-062026-04-01
M719GAC303070Stasys-C Standalone1GAC303-072026-04-01
M719GAC303080Stasys-C Standalone1GAC303-082026-04-01
M719GAC303090Stasys-C Standalone1GAC303-092026-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700780634583Erisma®-LPCLARIANCENKB2026-05-28
06009699900008Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900503Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900817Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900831Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900848Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900855Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900862Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900879Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900886Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900893Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900909Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900916Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900923Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900930Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900947Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900954Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900961Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900978Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900985Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900992Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901005Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901012Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901029Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901036Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901043Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901050Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901067Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901074Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901081Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28