FDA.reportPublic FDA data

RIVA Posterior Fixation System

Primary DI
00840493402642
Brand
RIVA Posterior Fixation System
Company
XENIX MEDICAL LLC
Model
FG1-31-045065
Catalog number
FG1-31-045065
Device description
BONE SCREW, FENESTRATED, 4.5mm X 65mm
Published
2025-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KWOProsthesis, Wrist, Carpal Scaphoid
NKBThoracolumbosacral Pedicle Screw System
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWOProsthesis, Wrist, Carpal ScaphoidOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251154000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251154000RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical2025-06-12NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840493402642PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840493402642008404934026428404934026420840493402642

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840493424712RIVA Pedicle Screw SystemFG1-16-231600FG1-16-2316002026-07-13
00840493424729RIVA Pedicle Screw SystemFG1-15-240040FG1-15-2400402026-07-13
00840493424736RIVA Pedicle Screw SystemFG1-15-240045FG1-15-2400452026-07-13
00840493424743RIVA Pedicle Screw SystemFG1-15-240050FG1-15-2400502026-07-13
00840493424750RIVA Pedicle Screw SystemFG1-15-240055FG1-15-2400552026-07-13
00840493424767RIVA Pedicle Screw SystemFG1-15-240060FG1-15-2400602026-07-13
00840493424774RIVA Pedicle Screw SystemFG1-15-240065FG1-15-2400652026-07-13
00840493424781RIVA Pedicle Screw SystemFG1-15-240070FG1-15-2400702026-07-13
00840493424798RIVA Pedicle Screw SystemFG1-15-240075FG1-15-2400752026-07-13
00840493424804RIVA Pedicle Screw SystemFG1-15-240080FG1-15-2400802026-07-13
00840493424811RIVA Pedicle Screw SystemFG1-15-240085FG1-15-2400852026-07-13
00840493424828RIVA Pedicle Screw SystemFG1-15-240090FG1-15-2400902026-07-13
00840493424835RIVA Pedicle Screw SystemFG1-15-240095FG1-15-2400952026-07-13
00840493424842RIVA Pedicle Screw SystemFG1-15-240100FG1-15-2401002026-07-13
00840493424859RIVA Pedicle Screw SystemFG1-15-240110FG1-15-2401102026-07-13
00840493424866RIVA Pedicle Screw SystemFG1-15-240120FG1-15-2401202026-07-13
00840493424873RIVA Pedicle Screw SystemFG1-15-240130FG1-15-2401302026-07-13
00840493424880RIVA Pedicle Screw SystemFG1-15-240140FG1-15-2401402026-07-13
00840493424897RIVA Pedicle Screw SystemFG1-15-240150FG1-15-2401502026-07-13
00840493424903RIVA Pedicle Screw SystemFG1-15-240200FG1-15-2402002026-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840642134797Salvo® Spine SystemSpine Wave, Inc.NKB2026-07-16
00840493424712RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424712RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424729RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424729RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424736RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424736RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424743RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424743RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424750RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424750RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424767RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424767RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424774RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424774RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424781RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424781RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424798RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424798RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424804RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424804RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424811RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424811RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424828RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424828RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424835RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424835RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424842RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424842RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424859RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13