FDA.reportPublic FDA data

RIVA Posterior Fixation System

Primary DI
00840493414164
Brand
RIVA Posterior Fixation System
Company
XENIX MEDICAL LLC
Model
FG1-A2-003035
Catalog number
FG1-A2-003035
Device description
Pedicle Tap, 3.5mm
Published
2025-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00840493414164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840493414164008404934141648404934141640840493414164

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840493421797RIVA Pedicle Screw SystemFG1-15-140550FG1-15-1405502026-05-06
00840493421803RIVA Pedicle Screw SystemFG1-15-140600FG1-15-1406002026-05-06
00840493421810RIVA Pedicle Screw SystemFG1-16-140040FG1-16-1400402026-05-06
00840493421827RIVA Pedicle Screw SystemFG1-16-140045FG1-16-1400452026-05-06
00840493421834RIVA Pedicle Screw SystemFG1-16-140450FG1-16-1404502026-05-06
00840493421841RIVA Pedicle Screw SystemFG1-16-140055FG1-16-1400552026-05-06
00840493421858RIVA Pedicle Screw SystemFG1-16-140060FG1-16-1400602026-05-06
00840493421865RIVA Pedicle Screw SystemFG1-16-140065FG1-16-1400652026-05-06
00840493421872RIVA Pedicle Screw SystemFG1-16-140070FG1-16-1400702026-05-06
00840493421889RIVA Pedicle Screw SystemFG1-16-140075FG1-16-1400752026-05-06
00840493421896RIVA Pedicle Screw SystemFG1-16-140080FG1-16-1400802026-05-06
00840493421902RIVA Pedicle Screw SystemFG1-16-140085FG1-16-1400852026-05-06
00840493421919RIVA Pedicle Screw SystemFG1-16-140090FG1-16-1400902026-05-06
00840493421926RIVA Pedicle Screw SystemFG1-16-140095FG1-16-1400952026-05-06
00840493421933RIVA Pedicle Screw SystemFG1-16-140100FG1-16-1401002026-05-06
00840493421940RIVA Pedicle Screw SystemFG1-16-140110FG1-16-1401102026-05-06
00840493421957RIVA Pedicle Screw SystemFG1-16-140120FG1-16-1401202026-05-06
00840493421964RIVA Pedicle Screw SystemFG1-16-140130FG1-16-1401302026-05-06
00840493421971RIVA Pedicle Screw SystemFG1-16-140140FG1-16-1401402026-05-06
00840493421988RIVA Pedicle Screw SystemFG1-16-140150FG1-16-1401502026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09120125220280Shark Screw® tapsurgebright GmbHHWX2026-04-30
10885862634351EquinoxeExactech, Inc.HWX2026-04-28
10705034577913N/AMedos International SàrlHWX2026-04-23
10705034577920N/AMedos International SàrlHWX2026-04-23
10705034577937N/AMedos International SàrlHWX2026-04-23
10705034577944N/AMedos International SàrlHWX2026-04-23
10705034577951N/AMedos International SàrlHWX2026-04-23
10705034577968N/AMedos International SàrlHWX2026-04-23
10705034577975N/AMedos International SàrlHWX2026-04-23
10705034577982N/AMedos International SàrlHWX2026-04-23
10705034577999N/AMedos International SàrlHWX2026-04-23
G079C5020000950Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22
G079C5020001000Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22
G079C5020001050Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22
07640450868374PERLA ®SpineArt SAHWX2025-11-10
07640450868381PERLA ®SpineArt SAHWX2025-11-10
08800308480564INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
08800308480571INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
08800308480588INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
08800308480595INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
08800308480601INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
09120125220136Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220143Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220150Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220167Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220174Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220181Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220198Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220204Shark Screw® tapsurgebright GmbHHWX2025-09-16
07640177820464Neo Medical Pedicle Screw SystemNeo Medical SAHWX2023-01-25