FDA.reportPublic FDA data

RIVA Pedicle Screw System

Primary DI
00840493421087
Brand
RIVA Pedicle Screw System
Company
XENIX MEDICAL LLC
Model
FG1-16-112120
Catalog number
FG1-16-112120
Device description
CONSTRAINED LORDOTIC ROD, 6.0mm x 120mm
Published
2026-04-27
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
NKOSystem, Balloon, Intra-Aortic And Control, Reprocessed
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
NKOSystem, Balloon, Intra-Aortic And Control, ReprocessedCardiovascular3
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
00840493421087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840493421087008404934210878404934210870840493421087

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system rodAn implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

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
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
00840493426525RIVA Pedicle Screw SystemFG1-16-302130FG1-16-3021302026-08-18
00840493426532RIVA Pedicle Screw SystemFG1-16-302140FG1-16-3021402026-08-18
00840493426549RIVA Pedicle Screw SystemFG1-16-302150FG1-16-3021502026-08-18
00840493426556RIVA Pedicle Screw SystemFG1-16-302200FG1-16-3022002026-08-18
00840493426563RIVA Pedicle Screw SystemFG1-16-302250FG1-16-3022502026-08-18
00840493426570RIVA Pedicle Screw SystemFG1-16-302300FG1-16-3023002026-08-18
00840493426587RIVA Pedicle Screw SystemFG1-16-302350FG1-16-3023502026-08-18
00840493426594RIVA Pedicle Screw SystemFG1-16-302400FG1-16-3024002026-08-18
00840493426600RIVA Pedicle Screw SystemFG1-16-302450FG1-16-3024502026-08-18
00840493426617RIVA Pedicle Screw SystemFG1-16-302500FG1-16-3025002026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810076335322MomentumUlrich Medical Usa, Inc.OLO2026-09-25
00810131884055TiLink-L Rescue Drill GuideSurgentec, LLCOLO2026-09-25
00810131884062TiLink-L Rescue DilatorSurgentec, LLCOLO2026-09-25
00810131884079TiLink-L Rescue Impact CapSurgentec, LLCOLO2026-09-25
00810131884086TiLink-L Rescue screw Drill bit – 10.5mmSurgentec, LLCOLO2026-09-25
00810131884857TiLink-L Sterilization Tray – Double StackSurgentec, LLCOLO2026-09-25
00810131884864TiLink-L Rescue CaddySurgentec, LLCOLO2026-09-25
00810017915125SABER-XA, Screw Ø5.0 x 22.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.KWQ2026-09-22
10888857598164Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598171Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598188Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598195Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598201Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598232Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
10888857598249Xia® 3 System - Serrato®VB Spine LLCKWQ2026-07-24
00810056993146corraCarlsmed, Inc.KWQ2026-01-30
00848486001414VIZADISCMAKO SURGICAL CORP.OLO2016-09-24
00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2015-08-05
04546540147257XIA IIStryker CorporationKWQ2014-12-08
04546540147769XIA IIStryker CorporationKWQ2014-12-08
04546540147806XIA IIStryker CorporationKWQ2014-12-08
04546540147905XIA IIStryker CorporationKWQ2014-12-08
04546540147912XIA IStryker CorporationKWQ2014-12-08