FDA.reportPublic FDA data

RIVA Pedicle Screw System

Primary DI
00840493422145
Brand
RIVA Pedicle Screw System
Company
XENIX MEDICAL LLC
Model
FG1-15-200055
Catalog number
FG1-15-200055
Device description
STRAIGHT ROD, 5.5mm X 55mm
Published
2026-06-01
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
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
00840493422145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840493422145008404934221458404934221450840493422145

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
DM exempt
false
Premarket exempt
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840493422268RIVA Pedicle Screw SystemFG1-15-200130FG1-15-2001302026-06-02
00840493422275RIVA Pedicle Screw SystemFG1-15-200140FG1-15-2001402026-06-02
00840493422282RIVA Pedicle Screw SystemFG1-15-200150FG1-15-2001502026-06-02
00840493422299RIVA Pedicle Screw SystemFG1-15-200200FG1-15-2002002026-06-02
00840493422305RIVA Pedicle Screw SystemFG1-15-200250FG1-15-2002502026-06-02
00840493422312RIVA Pedicle Screw SystemFG1-15-200300FG1-15-2003002026-06-02
00840493422329RIVA Pedicle Screw SystemFG1-15-200350FG1-15-2003502026-06-02
00840493422336RIVA Pedicle Screw SystemFG1-15-200400FG1-15-2004002026-06-02
00840493422343RIVA Pedicle Screw SystemFG1-15-200450FG1-15-2004502026-06-02
00840493422350RIVA Pedicle Screw SystemFG1-15-200500FG1-15-2005002026-06-02
00840493422367RIVA Pedicle Screw SystemFG1-15-200550FG1-15-2005502026-06-02
00840493422374RIVA Pedicle Screw SystemFG1-15-200600FG1-15-2006002026-06-02
00840493422381RIVA Pedicle Screw SystemFG1-16-200025FG1-16-2000252026-06-02
00840493422121RIVA Pedicle Screw SystemFG1-15-200045FG1-15-2000452026-06-01
00840493422138RIVA Pedicle Screw SystemFG1-15-200050FG1-15-2000502026-06-01
00840493422152RIVA Pedicle Screw SystemFG1-15-200060FG1-15-2000602026-06-01
00840493422169RIVA Pedicle Screw SystemFG1-15-200065FG1-15-2000652026-06-01
00840493422176RIVA Pedicle Screw SystemFG1-15-200070FG1-15-2000702026-06-01
00840493422183RIVA Pedicle Screw SystemFG1-15-200075FG1-15-2000752026-06-01
00840493422190RIVA Pedicle Screw SystemFG1-15-200080FG1-15-2000802026-06-01

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Primary DI, Brand, Company table
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