VYRSA V1

GUDID G418VYV1232608130

VYRSA VI Implant 8°, 23mm x 26mm x 13mm

Vyrsa Technologies

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

• Primary Device ID: G418VYV1232608130
• NIH Device Record Key: a6ec4249-052b-4269-a14d-0b5e099f1d79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VYRSA V1
• Version Model Number: VYV1-2326-0813
• Company DUNS: 083331321
• Company Name: Vyrsa Technologies
• 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
HIBCC	G418VYV1232608130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203503

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

[G418VYV1232608130]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-05
• Device Publish Date: 2024-01-27

On-Brand Devices [VYRSA V1]

• G418VYV1232608130: VYRSA VI Implant 8°, 23mm x 26mm x 13mm
• G418VYV1232608110: VYRSA VI Implant 8°, 23mm x 26mm x 11mm
• G418VYV1232608090: VYRSA VI Implant 8°, 23mm x 26mm x 9mm
• G418VYV11033210: VI Extended Inserter Assembly
• G418VYV1103121040: VI Inserter - Linkage Bar
• G418VYV11031210: VI Inserter Assembly