FDA.reportPublic FDA data

RIVA Posterior Fixation System

Primary DI
00840493414386
Brand
RIVA Posterior Fixation System
Company
XENIX MEDICAL LLC
Model
FG1-A2-005095
Catalog number
FG1-A2-005095
Device description
Cannulated Pedicle Tap, 9.5mm
Published
2025-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HWXTap, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWXTap, BoneOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840493414386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840493414386008404934143868404934143860840493414386

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080386764
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840493418704RIVA Pedicle Screw SystemFG1-15-0120110FG1-15-01201102026-03-24
00840493418711RIVA Pedicle Screw SystemFG1-15-0120120FG1-15-01201202026-03-24
00840493418728RIVA Pedicle Screw SystemFG1-15-0120130FG1-15-01201302026-03-24
00840493418735RIVA Pedicle Screw SystemFG1-15-0120140FG1-15-01201402026-03-24
00840493418742RIVA Pedicle Screw SystemFG1-15-0120150FG1-15-01201502026-03-24
00840493418759RIVA Pedicle Screw SystemFG1-16-0120025FG1-16-01200252026-03-24
00840493418766RIVA Pedicle Screw SystemFG1-16-0120030FG1-16-01200302026-03-24
00840493418773RIVA Pedicle Screw SystemFG1-16-0120035FG1-16-01200352026-03-24
00840493418780RIVA Pedicle Screw SystemFG1-16-0120040FG1-16-01200402026-03-24
00840493418797RIVA Pedicle Screw SystemFG1-16-0120045FG1-16-01200452026-03-24
00840493418803RIVA Pedicle Screw SystemFG1-16-0120050FG1-16-01200502026-03-24
00840493418810RIVA Pedicle Screw SystemFG1-16-0120055FG1-16-01200552026-03-24
00840493418827RIVA Pedicle Screw SystemFG1-16-0120060FG1-16-01200602026-03-24
00840493418834RIVA Pedicle Screw SystemFG1-16-0120065FG1-16-01200652026-03-24
00840493418841RIVA Pedicle Screw SystemFG1-16-0120070FG1-16-01200702026-03-24
00840493418858RIVA Pedicle Screw SystemFG1-16-0120075FG1-16-01200752026-03-24
00840493418865RIVA Pedicle Screw SystemFG1-16-0120080FG1-16-01200802026-03-24
00840493418872RIVA Pedicle Screw SystemFG1-16-0120085FG1-16-01200852026-03-24
00840493418889RIVA Pedicle Screw SystemFG1-16-0120090FG1-16-01200902026-03-24
00840493418896RIVA Pedicle Screw SystemFG1-16-0120095FG1-16-01200952026-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G832F00503450ACURA Stabilization SystemBioalign Inc.HWX2026-03-09
G832F00503550ACURA Stabilization SystemBioalign Inc.HWX2026-03-09
G832F00503650ACURA Stabilization SystemBioalign Inc.HWX2026-03-09
03662663131674Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131681Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131698Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131704Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131711Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131728Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131735Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131803Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131810Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131827Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131834Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
10886982351661NASynthes GmbHHWX2026-02-11
10886982351678NASynthes GmbHHWX2026-02-11
00810112597417TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHWX2026-02-10
00810112597424TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHWX2026-02-10
00810112597431TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHWX2026-02-10
07640177821324Neo Medical Pedicle screw kitNeo Medical SAHWX2026-02-09
00199150055296Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-26
00199150055227Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055234Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055241Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055258Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055265Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055272Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055289Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055302Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055319Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25