Erisma®-MIS 13435075

GUDID 03700780644100

MIS PRE-LORDOSED ROD

CLARIANCE

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 03700780644100
• NIH Device Record Key: a98ed4e1-824c-42fe-a408-a220d4075044
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Erisma®-MIS
• Version Model Number: 13435075
• Catalog Number: 13435075
• Company DUNS: 296568400
• Company Name: CLARIANCE
• 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: true
• 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

Customer Support Contacts

• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us
• Phone: 7738687041
• Email: s.chambat@clariance-spine.us

Device Dimensions

• Outer Diameter: 5.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 5.5 Millimeter
• Length: 80 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700780644100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162367

FDA Product Code

• MNH: Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

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

[03700780644100]

Moist Heat or Steam Sterilization

[03700780644100]

Moist Heat or Steam Sterilization

[03700780644100]

Moist Heat or Steam Sterilization

[03700780644100]

Moist Heat or Steam Sterilization

[03700780644100]

Moist Heat or Steam Sterilization

[03700780644100]

Moist Heat or Steam Sterilization

[03700780644100]

Moist Heat or Steam Sterilization

[03700780644100]

Moist Heat or Steam Sterilization

[03700780644100]

Moist Heat or Steam Sterilization

[03700780644100]

Moist Heat or Steam Sterilization

[03700780644100]

Moist Heat or Steam Sterilization

[03700780644100]

Moist Heat or Steam Sterilization

[03700780644100]

Moist Heat or Steam Sterilization

[03700780644100]

Moist Heat or Steam Sterilization

[03700780644100]

Moist Heat or Steam Sterilization

[03700780644100]

Moist Heat or Steam Sterilization

[03700780644100]

Moist Heat or Steam Sterilization

[03700780644100]

Moist Heat or Steam Sterilization

[03700780644100]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-06
• Device Publish Date: 2023-11-28

On-Brand Devices [Erisma®-MIS]

• 03700780644100: MIS PRE-LORDOSED ROD
• 03700780644094: MIS PRE-LORDOSED ROD
• 03700780644087: MIS PRE-LORDOSED ROD