FDA.report

RIVA Posterior Fixation System

Primary DI
00840493413938
Brand
RIVA Posterior Fixation System
Company
XENIX MEDICAL LLC
Model
FG1-A4-000044
Catalog number
FG1-A4-000044
Device description
CORONAL BENDER FULCRUM
Published
2025-12-02
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

Related Records

Product Codes

CodeName
HXWBender

Product Code Classifications

CodeDeviceSpecialtyClass
HXWBenderOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840493413938PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840493413938008404934139388404934139380840493413938

GMDN Terms

TermDefinition
Manual orthopaedic bender, reusableA manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. It is typically in the form of pliers, a rod-like (e.g., pin) or bench-top device. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
080386764
Device count
1
DM exempt
false
Premarket exempt
true
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

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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

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