FDA.reportPublic FDA data

RIVA Posterior Fixation System

Primary DI
00818345029774
Brand
RIVA Posterior Fixation System
Company
XENIX MEDICAL LLC
Model
FG1-A4-000060
Catalog number
FG1-A4-000060
Device description
Compressor
Published
2026-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HWNInstrument, Compression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWNInstrument, CompressionOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818345029774PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818345029774008183450297748183450297740818345029774

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation implant alignment toolA surgical instrument designed to facilitate the correct orientation (alignment) of an orthopaedic fixation implant, implants, or system of implants during orthopaedic surgery. It may be used, e.g., to align a series of bone screws in an implant system for posterior stabilization of the spine, or to align a spinal anatomical fixation implant. It is available in a variety of shapes and sizes and allows the surgeon to engage this device with the implant(s) and align them in the desired configuration. It is typically made of high-grade stainless steel or titanium alloy and will have profiled features to fit into the implant(s) to align them. This is a reusable device.

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
00840493425559RIVA Pedicle Screw SystemFG1-15-300600FG1-15-3006002026-08-03
00840493425566RIVA Pedicle Screw SystemFG1-16-300025FG1-16-3000252026-08-03
00840493425573RIVA Pedicle Screw SystemFG1-16-300030FG1-16-3000302026-08-03
00840493425580RIVA Pedicle Screw SystemFG1-16-300035FG1-16-3000352026-08-03
00840493425597RIVA Pedicle Screw SystemFG1-16-300040FG1-16-3000402026-08-03
00840493425603RIVA Pedicle Screw SystemFG1-16-300045FG1-16-3000452026-08-03
00840493425610RIVA Pedicle Screw SystemFG1-16-300050FG1-16-3000502026-08-03
00840493425627RIVA Pedicle Screw SystemFG1-16-300055FG1-16-3000552026-08-03
00840493425634RIVA Pedicle Screw SystemFG1-16-300060FG1-16-3000602026-08-03
00840493425641RIVA Pedicle Screw SystemFG1-16-300065FG1-16-3000652026-08-03
00840493425658RIVA Pedicle Screw SystemFG1-16-300070FG1-16-3000702026-08-03
00840493425665RIVA Pedicle Screw SystemFG1-16-300075FG1-16-3000752026-08-03
00840493425672RIVA Pedicle Screw SystemFG1-16-300080FG1-16-3000802026-08-03
00840493425689RIVA Pedicle Screw SystemFG1-16-300085FG1-16-3000852026-08-03
00840493425696RIVA Pedicle Screw SystemFG1-16-300090FG1-16-3000902026-08-03
00840493425702RIVA Pedicle Screw SystemFG1-16-300095FG1-16-3000952026-08-03
00840493425719RIVA Pedicle Screw SystemFG1-16-300100FG1-16-3001002026-08-03
00840493425726RIVA Pedicle Screw SystemFG1-16-300110FG1-16-3001102026-08-03
00840493425382RIVA Pedicle Screw SystemFG1-15-300085FG1-15-3000852026-07-28
00840493425399RIVA Pedicle Screw SystemFG1-15-300090FG1-15-3000902026-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810111228374Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-07-17
00810111228381Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-07-17
00840311251148Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251155Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251162Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251179Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251377Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311262953Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-27
00810111225281Instrument TrayTreace Medical Concepts, Inc.HWN2026-03-30
00840311245451Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-03-18
00810111226691Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-02-20
00810111226677Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-01-05
00810111226684Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-01-05
00810111226707Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-01-05
15060238201596Femoral Cement PressuriserSUMMIT MEDICAL LIMITEDHWN2025-01-10
00840298704637Songer® Spinal Cable SystemPioneer Surgical Technology, Inc.HWN2024-08-23
00841732164246GENERIC Surgical InstrumentsCTL Medical CorporationHWN2023-09-15
00841732164185GENERIC Surgical InstrumentsCTL Medical CorporationHWN2023-09-14
00643169350991Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWN2022-10-08
G079C5060000010Golden Isles Pedicle Screw SystemIntelivation, LLCHWN2022-09-23
00613994878137n/aMEDTRONIC SOFAMOR DANEK, INC.HWN2022-08-06
00721902875755N/AMEDTRONIC SOFAMOR DANEK, INC.HWN2022-08-06
20886982313437NASynthes GmbHHWN2022-07-29
20886982313444NASynthes GmbHHWN2022-07-29
20886982313451NASynthes GmbHHWN2022-07-29
20886982313468NASynthes GmbHHWN2022-07-29
20886982313475NASynthes GmbHHWN2022-07-29
20886982313482NASynthes GmbHHWN2022-07-29
20886982313499NASynthes GmbHHWN2022-07-29
20886982313505NASynthes GmbHHWN2022-07-29