FDA.reportPublic FDA data

RIVA Posterior Fixation System

Primary DI
00840493402642
Brand
RIVA Posterior Fixation System
Company
XENIX MEDICAL LLC
Model
FG1-31-045065
Catalog number
FG1-31-045065
Device description
BONE SCREW, FENESTRATED, 4.5mm X 65mm
Published
2025-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KWOProsthesis, Wrist, Carpal Scaphoid
NKBThoracolumbosacral Pedicle Screw System
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWOProsthesis, Wrist, Carpal ScaphoidOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2
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
00840493402642PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840493402642008404934026428404934026420840493402642

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

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
00840493441634RIVA Pedicle Screw SystemFG1-A3-021922FG1-A3-0219222026-10-05
00840493441641LUX Expandable Interbody SystemLE1-A4-000560LE1-A4-0005602026-10-05
00840493441658LUX Expandable Interbody SystemLE1-A4-000570LE1-A4-0005702026-10-05
00840493441665RIVA Pedicle Screw SystemFG1-A1-000063FG1-A1-0000632026-10-05
00840493441672RIVA Pedicle Screw SystemFG1-A3-000081FG1-A3-0000812026-10-05
00840493441689RIVA Pedicle Screw SystemFG1-A3-000040FG1-A3-0000402026-10-05
00840493441696RIVA Pedicle Screw SystemFG1-A5-000013FG1-A5-0000132026-10-05
00840493441719RIVA Pedicle Screw SystemFG1-A1-000064FG1-A1-0000642026-10-05
00840493442020Xenix Medical Universal HandleUN1-H0-423005UN1-H0-4230052026-10-05
00840493442037Xenix Medical Universal HandleUN1-H0-423006UN1-H0-4230062026-10-05
00840493426426RIVA Pedicle Screw SystemFG1-16-302065FG1-16-3020652026-08-18
00840493426433RIVA Pedicle Screw SystemFG1-16-302070FG1-16-3020702026-08-18
00840493426440RIVA Pedicle Screw SystemFG1-16-302075FG1-16-3020752026-08-18
00840493426457RIVA Pedicle Screw SystemFG1-16-302080FG1-16-3020802026-08-18
00840493426464RIVA Pedicle Screw SystemFG1-16-302085FG1-16-3020852026-08-18
00840493426471RIVA Pedicle Screw SystemFG1-16-302090FG1-16-3020902026-08-18
00840493426488RIVA Pedicle Screw SystemFG1-16-302095FG1-16-3020952026-08-18
00840493426495RIVA Pedicle Screw SystemFG1-16-302100FG1-16-3021002026-08-18
00840493426501RIVA Pedicle Screw SystemFG1-16-302110FG1-16-3021102026-08-18
00840493426518RIVA Pedicle Screw SystemFG1-16-302120FG1-16-3021202026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157120962ZAVATION SCREWZavation LLCNKB2026-10-15
00197157120979ZAVATION SCREWZavation LLCNKB2026-10-15
00197157120986ZAVATION SCREWZavation LLCNKB2026-10-15
00197157120993ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121006ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121013ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121020ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121037ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121044ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121051ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121068ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121075ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121082ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121099ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121105ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121112ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121129ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121136ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121143ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121150ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121167ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121174ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121181ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121198ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121204ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121211ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121228ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121235ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121242ZAVATION SCREWZavation LLCNKB2026-10-15
00197157121259ZAVATION SCREWZavation LLCNKB2026-10-15