FDA.reportPublic FDA data

SIros-X

Primary DI
M719GSIX1260
Brand
SIros-X
Company
Genesys Orthopedics Systems LLC
Model
1
Catalog number
GSI-X126
Device description
SIros-X Head Turner II
Published
2026-08-03
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

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
M719GSIX1260PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant driverA hand-held manual surgical instrument designed to impart force to an orthopaedic implantable device that is inserted to fix or fasten together bones. The device is frequently used to insert devices such as screws, nails, plates, or wires that are used to fix fractured or damaged bones and/or to attach orthopaedic prostheses to the bones. It is typically made of high-grade stainless steel or titanium (Ti). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
512-381-7070info@genesysspine.com

Regulatory Flags#

DUNS number
017921066
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M719GSIX1210TiLock1GSI-X1212026-08-18
M719IST80030C0TiLock1IS-T80030-C2026-08-18
M719IST80035C0TiLock1IS-T80035-C2026-08-18
M719IST80040C0TiLock1IS-T80040-C2026-08-18
M719IST80045C0TiLock1IS-T80045-C2026-08-18
M719IST80050C0TiLock1IS-T80050-C2026-08-18
M719IST80055C0TiLock1IS-T80055-C2026-08-18
M719IST80060C0TiLock1IS-T80060-C2026-08-18
M719IST80065C0TiLock1IS-T80065-C2026-08-18
M719IST80070C0TiLock1IS-T80070-C2026-08-18
M719IST80075C0TiLock1IS-T80075-C2026-08-18
M719IST80080C0TiLock1IS-T80080-C2026-08-18
M719IST80085C0TiLock1IS-T80085-C2026-08-18
M719IST80090C0TiLock1IS-T80090-C2026-08-18
M719IST80095C0TiLock1IS-T80095-C2026-08-18
M719IST80100C0TiLock1IS-T80100-C2026-08-18
M719IST80105C0TiLock1IS-T80105-C2026-08-18
M719IST80110C0TiLock1IS-T80110-C2026-08-18
M719IST80115C0TiLock1IS-T80115-C2026-08-18
M719IST80120C0TiLock1IS-T80120-C2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197157119171ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119188ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119195ZAVATION SCREWZavation LLCNKB2026-10-05
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00197157119225ZAVATION SCREWZavation LLCNKB2026-10-05
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00197157119249ZAVATION SCREWZavation LLCNKB2026-10-05
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00197157119324ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119331ZAVATION SCREWZavation LLCNKB2026-10-05
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00197157118303ZAVATION SCREWZavation LLCNKB2026-10-01