FDA.reportPublic FDA data

RIVA Posterior Fixation System

Primary DI
00818345029552
Brand
RIVA Posterior Fixation System
Company
XENIX MEDICAL LLC
Model
FG1-A1-000040
Catalog number
FG1-A1-000040
Device description
Steffe Probe - Straight
Published
2025-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HXBProbe

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXBProbeOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818345029552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818345029552008183450295528183450295520818345029552

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal/ENT/orthopaedic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used to explore cavities, wounds or fistulas during abdominal, ENT, and/or orthopaedic surgical interventions; it does not include stereotactic devices and is not dedicated to endoscopy. It may have a blunt bulbous, paddle-like, or pointed tip, may be single- or double-ended, and the shaft may be straight, bent or hooked. It is made of rigid or flexible metallic and/or synthetic polymer material. 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
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
04052536085507neon3Ulrich GmbH & Co. KGHXB2026-05-28
07640221373045PERLA ® TLSpineArt SAHXB2026-05-07
08800017271095ProbeCorentec Co., LtdHXB2026-04-10
10649111181665Sklar InstrumentsSKLAR CORPORATIONHXB2025-05-29
07640177820631Neo Medical Pedicle Screw SystemNeo Medical SAHXB2023-01-26
07898506815241QuinelatoSchobell Industrial LtdaHXB2023-01-09
07899798204461SchobellSchobell Industrial LtdaHXB2022-12-16
G079C5020010040Golden Isles Pedicle Screw SystemIntelivation, LLCHXB2022-10-26
10649111296673SklarSKLAR CORPORATIONHXB2019-03-19
10649111296932SklarSKLAR CORPORATIONHXB2019-03-19
10649111297120SklarSKLAR CORPORATIONHXB2019-03-19
10649111297496SklarSKLAR CORPORATIONHXB2019-03-19
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10649111176982Sklar®SKLAR CORPORATIONHXB2019-01-24
10649111151477Sklar®SKLAR CORPORATIONHXB2018-11-20
10649111153983Sklar®SKLAR CORPORATIONHXB2018-11-20
10649111155208Sklar®SKLAR CORPORATIONHXB2018-11-20
10649111156847Sklar®SKLAR CORPORATIONHXB2018-11-20
10649111220524Sklar®SKLAR CORPORATIONHXB2018-11-08
10649111220739Sklar®SKLAR CORPORATIONHXB2018-11-08
10649111083389Sklar®SKLAR CORPORATIONHXB2018-10-24
10649111013881Sklar®SKLAR CORPORATIONHXB2018-09-14
10649111018688Sklar®SKLAR CORPORATIONHXB2018-09-14