FDA.reportPublic FDA data

RIVA Posterior Fixation System

Primary DI
00840493406459
Brand
RIVA Posterior Fixation System
Company
XENIX MEDICAL LLC
Model
00840493406459
Catalog number
00840493406459
Device description
BONE SCREW, CORTICAL CANCELLOUS FENESTRATED, 8.5mm X 30mm
Published
2026-01-12
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
KWQAppliance, Fixation, Spinal Intervertebral Body
NKBThoracolumbosacral Pedicle Screw System
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
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
00840493406459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840493406459008404934064598404934064590840493406459

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
00840493422596RIVA Pedicle Screw SystemFG1-16-200200FG1-16-2002002026-06-05
00840493422602RIVA Pedicle Screw SystemFG1-16-200250FG1-16-2002502026-06-05
00840493422619RIVA Pedicle Screw SystemFG1-16-200300FG1-16-2003002026-06-05
00840493422626RIVA Pedicle Screw SystemFG1-16-200350FG1-16-2003502026-06-05
00840493422633RIVA Pedicle Screw SystemFG1-16-200400FG1-16-2004002026-06-05
00840493422640RIVA Pedicle Screw SystemFG1-16-200450FG1-16-2004502026-06-05
00840493422657RIVA Pedicle Screw SystemFG1-16-200500FG1-16-2005002026-06-05
00840493422664RIVA Pedicle Screw SystemFG1-16-200550FG1-16-2005502026-06-05
00840493422671RIVA Pedicle Screw SystemFG1-16-200600FG1-16-2006002026-06-05
00840493422688RIVA Pedicle Screw SystemFG1-15-201200FG1-15-2012002026-06-05
00840493422695RIVA Pedicle Screw SystemFG1-15-201250FG1-15-2012502026-06-05
00840493422701RIVA Pedicle Screw SystemFG1-15-201300FG1-15-2013002026-06-05
00840493422718RIVA Pedicle Screw SystemFG1-15-201350FG1-15-2013502026-06-05
00840493422725RIVA Pedicle Screw SystemFG1-15-201400FG1-15-2014002026-06-05
00840493422732RIVA Pedicle Screw SystemFG1-15-201450FG1-15-2014502026-06-05
00840493422749RIVA Pedicle Screw SystemFG1-15-201500FG1-15-2015002026-06-05
00840493422756RIVA Pedicle Screw SystemFG1-15-201550FG1-15-2015502026-06-05
00840493422763RIVA Pedicle Screw SystemFG1-15-201600FG1-15-2016002026-06-05
00840493422770RIVA Pedicle Screw SystemFG1-16-201200FG1-16-2012002026-06-05
00840493422787RIVA Pedicle Screw SystemFG1-16-201250FG1-16-2012502026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017913664Saber-C Body (PT), 12x15x7 6 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914609Saber-C Plate, 14x17x6 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914616Saber-C Plate, 14x17x7 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017914623Saber-C Plate, 14x17x8 12 deg.ELEVATION SPINE, INC.KWQ2026-06-05
00810017915354Saber-C, Spike Driver 5-7, MedialELEVATION SPINE, INC.KWQ2026-06-05
00810017915361Saber-C, Spike Driver 5-7, LateralELEVATION SPINE, INC.KWQ2026-06-05
00810017915378Saber-C, Spike Driver 8-9, MedialELEVATION SPINE, INC.KWQ2026-06-05
00810017915385Saber-C, Spike Driver 8-9, LateralELEVATION SPINE, INC.KWQ2026-06-05
00840283407949VyPlate™VY SPINE LLCKWQ2026-06-05
00840493422596RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422596RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422596RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422602RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422602RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422602RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422619RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422619RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422619RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422626RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422626RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422626RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422633RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422633RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422633RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422640RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422640RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422640RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05
00840493422657RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422657RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-05
00840493422657RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-06-05