FDA.reportPublic FDA data

RIVA Pedicle Screw System

Primary DI
00840493402000
Brand
RIVA Pedicle Screw System
Company
XENIX MEDICAL LLC
Model
FG1-30-095090
Catalog number
FG1-30-095090
Device description
BONE SCREW, 9.5mm X 90mm
Published
2025-10-29
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
KWQAppliance, Fixation, Spinal Intervertebral Body
NKBThoracolumbosacral Pedicle Screw System
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
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
00840493402000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840493402000008404934020008404934020000840493402000

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
00840493422398RIVA Pedicle Screw SystemFG1-16-200030FG1-16-2000302026-06-03
00840493422404RIVA Pedicle Screw SystemFG1-16-200035FG1-16-2000352026-06-03
00840493422411RIVA Pedicle Screw SystemFG1-16-200040FG1-16-2000402026-06-03
00840493422428RIVA Pedicle Screw SystemFG1-16-200045FG1-16-2000452026-06-03
00840493422435RIVA Pedicle Screw SystemFG1-16-200050FG1-16-2000502026-06-03
00840493422442RIVA Pedicle Screw SystemFG1-16-200055FG1-16-2000552026-06-03
00840493422459RIVA Pedicle Screw SystemFG1-16-200060FG1-16-2000602026-06-03
00840493422466RIVA Pedicle Screw SystemFG1-16-200065FG1-16-2000652026-06-03
00840493422473RIVA Pedicle Screw SystemFG1-16-200070FG1-16-2000702026-06-03
00840493422480RIVA Pedicle Screw SystemFG1-16-200075FG1-16-2000752026-06-03
00840493422497RIVA Pedicle Screw SystemFG1-16-200080FG1-16-2000802026-06-03
00840493422503RIVA Pedicle Screw SystemFG1-16-200085FG1-16-2000852026-06-03
00840493422510RIVA Pedicle Screw SystemFG1-16-200090FG1-16-2000902026-06-03
00840493422527RIVA Pedicle Screw SystemFG1-16-200095FG1-16-2000952026-06-03
00840493422534RIVA Pedicle Screw SystemFG1-16-200100FG1-16-2001002026-06-03
00840493422541RIVA Pedicle Screw SystemFG1-16-200110FG1-16-2001102026-06-03
00840493422558RIVA Pedicle Screw SystemFG1-16-200120FG1-16-2001202026-06-03
00840493422565RIVA Pedicle Screw SystemFG1-16-200130FG1-16-2001302026-06-03
00840493422572RIVA Pedicle Screw SystemFG1-16-200140FG1-16-2001402026-06-03
00840493422589RIVA Pedicle Screw SystemFG1-16-200150FG1-16-2001502026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157059521ZAVATION RODZavation LLCNKB2026-06-04
00197157059538ZAVATION RODZavation LLCNKB2026-06-04
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00197157059552ZAVATION RODZavation LLCNKB2026-06-04
00197157059569ZAVATION RODZavation LLCNKB2026-06-04
00197157059576ZAVATION RODZavation LLCNKB2026-06-04
00197157059583ZAVATION RODZavation LLCNKB2026-06-04
00197157059590ZAVATION RODZavation LLCNKB2026-06-04
00197157059606ZAVATION RODZavation LLCNKB2026-06-04
00197157059613ZAVATION RODZavation LLCNKB2026-06-04
00197157059620ZAVATION RODZavation LLCNKB2026-06-04
00197157059637ZAVATION RODZavation LLCNKB2026-06-04
00197157059644ZAVATION RODZavation LLCNKB2026-06-04
00197157059651ZAVATION RODZavation LLCNKB2026-06-04
00197157059668ZAVATION RODZavation LLCNKB2026-06-04
08809986491145CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491152CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491169CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491176CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491183CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491190CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491206CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491213CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491220CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491237CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491244CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491251CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491268CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491275CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04
08809986491282CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED CO. ,LTD.KWQ2026-06-04