RIVA Pedicle Screw System FG1-15-0120130

GUDID 00840493418728

CONSTRAINED LORDOTIC ROD, 5.5mm x 130mm

XENIX MEDICAL LLC

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00840493418728
• NIH Device Record Key: c18afbe7-88e3-4415-8a2c-a97ad10afdc8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIVA Pedicle Screw System
• Version Model Number: FG1-15-0120130
• Catalog Number: FG1-15-0120130
• Company DUNS: 080386764
• Company Name: XENIX MEDICAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840493418728 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251154

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00840493418728]

Moist Heat or Steam Sterilization

[00840493418728]

Moist Heat or Steam Sterilization

[00840493418728]

Moist Heat or Steam Sterilization

[00840493418728]

Moist Heat or Steam Sterilization

[00840493418728]

Moist Heat or Steam Sterilization

[00840493418728]

Moist Heat or Steam Sterilization

[00840493418728]

Moist Heat or Steam Sterilization

[00840493418728]

Moist Heat or Steam Sterilization

[00840493418728]

Moist Heat or Steam Sterilization

[00840493418728]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-04-01
• Device Publish Date: 2026-03-24

On-Brand Devices [RIVA Pedicle Screw System]

• 00840493418698: CONSTRAINED LORDOTIC ROD, 5.5mm x 100mm
• 00840493418681: CONSTRAINED LORDOTIC ROD, 5.5mm x 95mm
• 00840493418971: PRECONTOUR ROD, 5.5mm x 100mm
• 00840493418964: PRECONTOUR ROD, 5.5mm x 90mm
• 00840493418957: CONSTRAINED LORDOTIC ROD, 6.0mm x 150mm
• 00840493418940: CONSTRAINED LORDOTIC ROD, 6.0mm x 140mm
• 00840493418933: CONSTRAINED LORDOTIC ROD, 6.0mm x 130mm
• 00840493418926: CONSTRAINED LORDOTIC ROD, 6.0mm x 120mm
• 00840493418919: CONSTRAINED LORDOTIC ROD, 6.0mm x 110mm
• 00840493418902: CONSTRAINED LORDOTIC ROD, 6.0mm x 100mm
• 00840493418896: CONSTRAINED LORDOTIC ROD, 6.0mm x 95mm
• 00840493418889: CONSTRAINED LORDOTIC ROD, 6.0mm x 90mm
• 00840493418872: CONSTRAINED LORDOTIC ROD, 6.0mm x 85mm
• 00840493418865: CONSTRAINED LORDOTIC ROD, 6.0mm x 80mm
• 00840493418858: CONSTRAINED LORDOTIC ROD, 6.0mm x 75mm
• 00840493418841: CONSTRAINED LORDOTIC ROD, 6.0mm x 70mm
• 00840493418834: CONSTRAINED LORDOTIC ROD, 6.0mm x 65mm
• 00840493418827: CONSTRAINED LORDOTIC ROD, 6.0mm x 60mm
• 00840493418810: CONSTRAINED LORDOTIC ROD, 6.0mm x 55mm
• 00840493418803: CONSTRAINED LORDOTIC ROD, 6.0mm x 50mm
• 00840493418797: CONSTRAINED LORDOTIC ROD, 6.0mm x 45mm
• 00840493418780: CONSTRAINED LORDOTIC ROD, 6.0mm x 40mm
• 00840493418773: CONSTRAINED LORDOTIC ROD, 6.0mm x 35mm
• 00840493418766: CONSTRAINED LORDOTIC ROD, 6.0mm x 30mm
• 00840493418759: CONSTRAINED LORDOTIC ROD, 6.0mm x 25mm
• 00840493418742: CONSTRAINED LORDOTIC ROD, 5.5mm x 150mm
• 00840493418735: CONSTRAINED LORDOTIC ROD, 5.5mm x 140mm
• 00840493418728: CONSTRAINED LORDOTIC ROD, 5.5mm x 130mm
• 00840493418711: CONSTRAINED LORDOTIC ROD, 5.5mm x 120mm
• 00840493418704: CONSTRAINED LORDOTIC ROD, 5.5mm x 110mm