FDA.reportPublic FDA data

RIVA Pedicle Screw System

Primary DI
00840493405049
Brand
RIVA Pedicle Screw System
Company
XENIX MEDICAL LLC
Model
FG1-32-095030
Catalog number
FG1-32-095030
Device description
BONE SCREW, CORTICAL CANCELLOUS, 9.5mm X 30mm
Published
2025-10-24
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
00840493405049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840493405049008404934050498404934050490840493405049

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