FDA.reportPublic FDA data

RIVA Posterior Fixation System

Primary DI
00840493414690
Brand
RIVA Posterior Fixation System
Company
XENIX MEDICAL LLC
Model
FG1-A2-103065
Catalog number
FG1-A2-103065
Device description
Nav Pedicle Tap, 6.5mm
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
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
00840493414690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840493414690008404934146908404934146900840493414690

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
00840493423166RIVA Pedicle Screw SystemFG1-16-202025FG1-16-2020252026-06-08
00840493423173RIVA Pedicle Screw SystemFG1-16-202030FG1-16-2020302026-06-08
00840493423180RIVA Pedicle Screw SystemFG1-16-202035FG1-16-2020352026-06-08
00840493423197RIVA Pedicle Screw SystemFG1-16-202040FG1-16-2020402026-06-08
00840493423203RIVA Pedicle Screw SystemFG1-16-202045FG1-16-2020452026-06-08
00840493423210RIVA Pedicle Screw SystemFG1-16-202050FG1-16-2020502026-06-08
00840493423227RIVA Pedicle Screw SystemFG1-16-202055FG1-16-2020552026-06-08
00840493423234RIVA Pedicle Screw SystemFG1-16-202060FG1-16-2020602026-06-08
00840493423241RIVA Pedicle Screw SystemFG1-16-202065FG1-16-2020652026-06-08
00840493423258RIVA Pedicle Screw SystemFG1-16-202070FG1-16-2020702026-06-08
00840493423265RIVA Pedicle Screw SystemFG1-16-202075FG1-16-2020752026-06-08
00840493423272RIVA Pedicle Screw SystemFG1-16-202080FG1-16-2020802026-06-08
00840493423289RIVA Pedicle Screw SystemFG1-16-202085FG1-16-2020852026-06-08
00840493423296RIVA Pedicle Screw SystemFG1-16-202090FG1-16-2020902026-06-08
00840493423302RIVA Pedicle Screw SystemFG1-16-202095FG1-16-2020952026-06-08
00840493423319RIVA Pedicle Screw SystemFG1-16-202100FG1-16-2021002026-06-08
00840493423326RIVA Pedicle Screw SystemFG1-16-202110FG1-16-2021102026-06-08
00840493423333RIVA Pedicle Screw SystemFG1-16-202120FG1-16-2021202026-06-08
00840493423340RIVA Pedicle Screw SystemFG1-16-202130FG1-16-2021302026-06-08
00840493423357RIVA Pedicle Screw SystemFG1-16-202140FG1-16-2021402026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493423166RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423173RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423180RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423197RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423203RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423210RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423227RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423234RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423241RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423258RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423265RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423272RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423289RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423296RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423302RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423319RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423326RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423333RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423340RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423357RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423364RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423371RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423388RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423395RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423401RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423418RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423425RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423432RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423449RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423456RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08