FDA.reportPublic FDA data

SIros-O Sacroiliac Joint Fusion System

Primary DI
M719GSI256SSR0
Brand
SIros-O Sacroiliac Joint Fusion System
Company
Genesys Orthopedics Systems LLC
Model
1
Catalog number
GSI256-SSR
Device description
.0625 SI-O Wire - Stainless Steel, Sharp, Regular
Published
2025-10-16
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
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233595000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233595000Genesys Spine Sacroiliac Joint Fusion System with NavigationGenesys Spine2024-03-29OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M719GSI256SSR0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic intraoperative positioning pin, reusableA nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. 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
M719GL201TL0SIros-X1GL201T-L2026-07-23
M179GSI265STS0Sacroiliac Joint Fusion1GSI265-ST-S2026-07-14
M719G120140SIros-X12026-07-14
M719GGSI265XLGS0Sacroiliac Joint Fusion1GSI265-XLG-S2026-07-14
M719GL2290TiLock1GL2292026-07-14
M719GLL100QC03DP Lumbar Interbody System1GLL100-QC2026-07-14
M719GLL101QC03DP Lumbar Interbody System1GLL101-QC2026-07-14
M719GLL106QC03DP Lumbar Interbody System1GLL106-QC2026-07-14
M719GLL107QC03DP Lumbar Interbody System1GLL107-QC2026-07-14
M719GCL05L0Apache1GCL-05-L2015-08-31
M719GCL06L0Apache1GCL-06-L2015-08-31
M719GCL06S0Apache1GCL-06-S2015-08-31
M719GCL07L0Apache1GCL-07-L2015-08-31
M719GCL07S0Apache1GCL-07-S2015-08-31
M719GCL08L0Apache1GCL-08-L2015-08-31
M719GCL08S0Apache1GCL-08-S2015-08-31
M719GCL09L0Apache1GCL-09-L2015-08-31
M719GCL09S0Apache1GCL-09-S2015-08-31
M719GCL10L0Apache1GCL-10-L2015-08-31
M719GCL10S0Apache1GCL-10-S2015-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000914097Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-07-24
M719GL201TL0SIros-XGenesys Orthopedics Systems LLCOLO2026-07-23
00840466901035PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901042PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901059PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901066PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901073PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901080PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901097PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901103PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901110PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901127PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901141PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901158PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901165PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901172PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901479PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901486PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901493PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901509PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901516PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901523PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901530PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901547PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901554PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901561PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901578PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901585PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901592PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901608PrimusSPINAL ELEMENTS, INC.OLO2026-07-21