FDA.reportPublic FDA data

RIVA Posterior Fixation System

Primary DI
00840493414997
Brand
RIVA Posterior Fixation System
Company
XENIX MEDICAL LLC
Model
FG1-A4-000101
Catalog number
FG1-A4-000101
Device description
Axial Reducer Driver
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840493414997PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840493414997008404934149978404934149970840493414997

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic rod reducerA heavy-duty, hand-held manual surgical instrument intended to be used to reduce or seat an implantable rod into the saddle of an implant (i.e., bone screw, spinal hook) used as a component of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. When the rod lies medial or lateral to the implant channel this instrument allows for controlled translation of the rod into the saddle of the screws and/or hooks. The surgeon is able to control the positioning (bending) of the rod into the saddle. Once the rod is securely seated in the saddle it is locked into position with a plug or a setscrew. 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
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

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