RIVA Posterior Fixation System FG1-45-220070

GUDID 00840493415703

Closed Lateral Connector, 70mm

XENIX MEDICAL LLC

Bone-screw internal spinal fixation system connector

• Primary Device ID: 00840493415703
• NIH Device Record Key: 124fc20d-e9ad-456f-aab9-9bfae1d58cdf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIVA Posterior Fixation System
• Version Model Number: FG1-45-220070
• Catalog Number: FG1-45-220070
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840493415703 [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

[00840493415703]

Moist Heat or Steam Sterilization

[00840493415703]

Moist Heat or Steam Sterilization

[00840493415703]

Moist Heat or Steam Sterilization

[00840493415703]

Moist Heat or Steam Sterilization

[00840493415703]

Moist Heat or Steam Sterilization

[00840493415703]

Moist Heat or Steam Sterilization

[00840493415703]

Moist Heat or Steam Sterilization

[00840493415703]

Moist Heat or Steam Sterilization

[00840493415703]

Moist Heat or Steam Sterilization

[00840493415703]

Moist Heat or Steam Sterilization

[00840493415703]

Moist Heat or Steam Sterilization

[00840493415703]

Moist Heat or Steam Sterilization

[00840493415703]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-23
• Device Publish Date: 2025-09-15

On-Brand Devices [RIVA Posterior Fixation System]

• 00840493415413: Head Remover Sleeve
• 00840493415376: Pedicle Screw Instrument Set 2 Middle Level
• 00840493415369: Pedicle Screw Instrument Set 2 Top Level
• 00840493415352: Pedicle Screw Instrument Set 2 Lid
• 00840493415345: Pedicle Screw Instrument Set 2 Base
• 00840493415338: Pedicle Screw Instrument Set 1 Bottom Level
• 00840493415321: Pedicle Screw Instrument Set 1 Top Level
• 00840493415314: Pedicle Screw Instrument Set 1 Lid
• 00840493415307: Pedicle Screw Instrument Set 1 Base
• 00840493415291: Lordotic Rod Caddy Lid
• 00840493415284: Lordotic Rod Caddy Base
• 00840493415277: 5.5 Cross Connector Caddy Lid
• 00840493415260: 5.5 Cross Connector Caddy Base
• 00840493415253: Set Screw Caddy Lid
• 00840493415246: Set Screw Caddy Base
• 00840493415239: Specialty Head and Connector Caddy Lid
• 00840493415222: Specialty Head and Connector Caddy Base
• 00840493415215: Reduction Head Caddy Lid
• 00840493415208: Reduction Head Caddy Base
• 00840493415192: Standard Head Caddy Lid
• 00840493415185: Standard Head Caddy Base
• 00840493415178: 4.5/8.5 Screw Caddy Lid
• 00840493415161: 4.5/8.5 Screw Caddy Base
• 00840493415154: 7.5 Screw Caddy Lid
• 00840493415147: 7.5 Screw Caddy Base
• 00840493415130: 6.5 Screw Caddy Lid
• 00840493415123: 6.5 Screw Caddy Base
• 00840493415116: 5.5 Screw Caddy Lid
• 00840493415109: 5.5 Screw Caddy Base
• 00840493415093: Implant Set Bottom Level
• 00840493415086: Implant Set Top Level
• 00840493415079: Implant Tray Lid
• 00840493415062: Implant Tray Base
• 00840493415017: Screw Measurement and Holder
• 00840493415000: Axial Reducer Counter Torque
• 00840493414997: Axial Reducer Driver
• 00840493414539: Nav Awl-Tip Pedicle Tap, 7.5mm
• 00840493414522: Nav Awl-Tip Pedicle Tap, 6.5mm
• 00840493414515: Nav Awl-Tip Pedicle Tap, 5.5mm
• 00840493414508: Nav Awl-Tip Pedicle Tap, 4.5mm
• 00840493413976: Screw Adjuster
• 00840493413969: BONE SCREW INSERTER, NAV
• 00840493413884: PEDICLE FINDER, DOUBLE SIDED
• 00840493413877: PEDICLE FINDER, STRAIGHT
• 00840493413853: COUNTER TORQUE, CROSSBAR
• 00840493413846: FINAL TIGHTENER, CROSSBAR
• 00840493413815: Rod Rocker
• 00840493413808: Rod Inserter
• 00840493413778: Extended Tab Breaker, Tube
• 00840493413747: Head Inserter