VYRSA Fix

GUDID G418VYFI110450

Ø11.0mm Bone Screw, Cannulated, 45mm

Vyrsa Technologies

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

• Primary Device ID: G418VYFI110450
• NIH Device Record Key: cde081c0-f4b3-423f-b283-7df2285642a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VYRSA Fix
• Version Model Number: VYFI-11-045
• 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	G418VYFI110450 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162121

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

[G418VYFI110450]

Moist Heat or Steam Sterilization

[G418VYFI110450]

Moist Heat or Steam Sterilization

[G418VYFI110450]

Moist Heat or Steam Sterilization

[G418VYFI110450]

Moist Heat or Steam Sterilization

[G418VYFI110450]

Moist Heat or Steam Sterilization

[G418VYFI110450]

Moist Heat or Steam Sterilization

[G418VYFI110450]

Moist Heat or Steam Sterilization

[G418VYFI110450]

Moist Heat or Steam Sterilization

[G418VYFI110450]

Moist Heat or Steam Sterilization

[G418VYFI110450]

Moist Heat or Steam Sterilization

[G418VYFI110450]

Moist Heat or Steam Sterilization

[G418VYFI110450]

Moist Heat or Steam Sterilization

[G418VYFI110450]

Moist Heat or Steam Sterilization

[G418VYFI110450]

Moist Heat or Steam Sterilization

[G418VYFI110450]

Moist Heat or Steam Sterilization

[G418VYFI110450]

Moist Heat or Steam Sterilization

[G418VYFI110450]

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 Fix]

• G418VYFI110650: Ø11.0mm Bone Screw, Cannulated, 65mm
• G418VYFI110600: Ø11.0mm Bone Screw, Cannulated, 60mm
• G418VYFI110550: Ø11.0mm Bone Screw, Cannulated, 55mm
• G418VYFI110500: Ø11.0mm Bone Screw, Cannulated, 50mm
• G418VYFI110450: Ø11.0mm Bone Screw, Cannulated, 45mm
• G418VYFI110400: Ø11.0mm Bone Screw, Cannulated, 40mm
• G418VYFI110350: Ø11.0mm Bone Screw, Cannulated, 35mm
• G418VYFI070700: ø7.0mm Bone Screw, Cannulated, 70mm
• G418VYFI070650: ø7.0mm Bone Screw, Cannulated, 65mm
• G418VYFI070600: ø7.0mm Bone Screw, Cannulated, 60mm
• G418VYFI070550: ø7.0mm Bone Screw, Cannulated, 55mm
• G418VYFI070500: ø7.0mm Bone Screw, Cannulated, 50mm
• G418VYFI070450: ø7.0mm Bone Screw, Cannulated, 45mm
• G418VYFI070400: ø7.0mm Bone Screw, Cannulated, 40mm
• G418VYFI070350: ø7.0mm Bone Screw, Cannulated, 35mm
• G418VYFI070300: ø7.0mm Bone Screw, Cannulated, 30mm