FDA.reportPublic FDA data

RIVA Pedicle Screw System

Primary DI
00818345029620
Brand
RIVA Pedicle Screw System
Company
XENIX MEDICAL LLC
Model
FG1-A3-000082
Catalog number
FG1-A3-000082
Device description
Head Turner - T-Handle
Published
2025-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LYQAccessories, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYQAccessories, Fixation, Spinal Intervertebral BodyOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818345029620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818345029620008183450296208183450296200818345029620

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080386764
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840493421797RIVA Pedicle Screw SystemFG1-15-140550FG1-15-1405502026-05-06
00840493421803RIVA Pedicle Screw SystemFG1-15-140600FG1-15-1406002026-05-06
00840493421810RIVA Pedicle Screw SystemFG1-16-140040FG1-16-1400402026-05-06
00840493421827RIVA Pedicle Screw SystemFG1-16-140045FG1-16-1400452026-05-06
00840493421834RIVA Pedicle Screw SystemFG1-16-140450FG1-16-1404502026-05-06
00840493421841RIVA Pedicle Screw SystemFG1-16-140055FG1-16-1400552026-05-06
00840493421858RIVA Pedicle Screw SystemFG1-16-140060FG1-16-1400602026-05-06
00840493421865RIVA Pedicle Screw SystemFG1-16-140065FG1-16-1400652026-05-06
00840493421872RIVA Pedicle Screw SystemFG1-16-140070FG1-16-1400702026-05-06
00840493421889RIVA Pedicle Screw SystemFG1-16-140075FG1-16-1400752026-05-06
00840493421896RIVA Pedicle Screw SystemFG1-16-140080FG1-16-1400802026-05-06
00840493421902RIVA Pedicle Screw SystemFG1-16-140085FG1-16-1400852026-05-06
00840493421919RIVA Pedicle Screw SystemFG1-16-140090FG1-16-1400902026-05-06
00840493421926RIVA Pedicle Screw SystemFG1-16-140095FG1-16-1400952026-05-06
00840493421933RIVA Pedicle Screw SystemFG1-16-140100FG1-16-1401002026-05-06
00840493421940RIVA Pedicle Screw SystemFG1-16-140110FG1-16-1401102026-05-06
00840493421957RIVA Pedicle Screw SystemFG1-16-140120FG1-16-1401202026-05-06
00840493421964RIVA Pedicle Screw SystemFG1-16-140130FG1-16-1401302026-05-06
00840493421971RIVA Pedicle Screw SystemFG1-16-140140FG1-16-1401402026-05-06
00840493421988RIVA Pedicle Screw SystemFG1-16-140150FG1-16-1401502026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493426709neoWave Lumbar, StraightXENIX MEDICAL LLCLYQ2026-04-29
00859373004029PasserEMPIRICAL SPINE, INC.LYQ2026-03-27
00859373004036HolderEMPIRICAL SPINE, INC.LYQ2026-03-27
00859373004043Symbol PlateEMPIRICAL SPINE, INC.LYQ2026-03-27
00859373004050DriverEMPIRICAL SPINE, INC.LYQ2026-03-27
00859373004067Tensioner ClipEMPIRICAL SPINE, INC.LYQ2026-03-27
00859373004074TensionerEMPIRICAL SPINE, INC.LYQ2026-03-27
00840493416441LUX Expandable Interbody SystemXENIX MEDICAL LLCLYQ2026-02-23
00840493416458LUX Expandable Interbody SystemXENIX MEDICAL LLCLYQ2026-02-23
00840493413952RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-12-02
00818345029590RIVA Pedicle Screw SystemXENIX MEDICAL LLCLYQ2025-10-27
00818345029606RIVA Pedicle Screw SystemXENIX MEDICAL LLCLYQ2025-10-27
00818345029637RIVA Pedicle Screw SystemXENIX MEDICAL LLCLYQ2025-10-27
00818345029644RIVA Pedicle Screw SystemXENIX MEDICAL LLCLYQ2025-10-27
G616G1090912DS1PTSPt. Solutions, LLCLYQ2025-10-06
G616G1090914DS1PTSPt. Solutions, LLCLYQ2025-10-06
G616G1090916DS1PTSPt. Solutions, LLCLYQ2025-10-06
G616G190912DS0PTSPt. Solutions, LLCLYQ2025-10-06
G616G190914DS0PTSPt. Solutions, LLCLYQ2025-10-06
G616G190916DS0PTSPt. Solutions, LLCLYQ2025-10-06
00818345029583RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-08-15
00818345029613RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-08-15
00818345029934RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-08-15
00818345029958RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-08-15
00840493413747RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-08-15
00840493413808RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-08-15
00840493415413RIVA Posterior Fixation SystemXENIX MEDICAL LLCLYQ2025-08-15
G616S1090912DS1PTSPt. Solutions, LLCLYQ2025-03-10
G616S1090914DS1PTSPt. Solutions, LLCLYQ2025-03-10
G616S1090916DS1PTSPt. Solutions, LLCLYQ2025-03-10