Erisma®-MIS 13058510

GUDID 03700780650675

LATERAL MIS UNIPLANAR SCREW

CLARIANCE

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 03700780650675
• NIH Device Record Key: 3183bcb9-edc9-439b-a20b-6d2371f44e0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Erisma®-MIS
• Version Model Number: 13058510
• Catalog Number: 13058510
• 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: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us
• Phone: +1 773 868 7041
• Email: s.chambat@clariance-spine.us

Device Dimensions

• Outer Diameter: 8.5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 100 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700780650675 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241863

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[03700780650675]

Moist Heat or Steam Sterilization

[03700780650675]

Moist Heat or Steam Sterilization

[03700780650675]

Moist Heat or Steam Sterilization

[03700780650675]

Moist Heat or Steam Sterilization

[03700780650675]

Moist Heat or Steam Sterilization

[03700780650675]

Moist Heat or Steam Sterilization

[03700780650675]

Moist Heat or Steam Sterilization

[03700780650675]

Moist Heat or Steam Sterilization

[03700780650675]

Moist Heat or Steam Sterilization

[03700780650675]

Moist Heat or Steam Sterilization

[03700780650675]

Moist Heat or Steam Sterilization

[03700780650675]

Moist Heat or Steam Sterilization

[03700780650675]

Moist Heat or Steam Sterilization

[03700780650675]

Moist Heat or Steam Sterilization

[03700780650675]

Moist Heat or Steam Sterilization

[03700780650675]

Moist Heat or Steam Sterilization

[03700780650675]

Moist Heat or Steam Sterilization

[03700780650675]

Moist Heat or Steam Sterilization

[03700780650675]

Moist Heat or Steam Sterilization

[03700780650675]

Moist Heat or Steam Sterilization

[03700780650675]

Moist Heat or Steam Sterilization

[03700780650675]

Moist Heat or Steam Sterilization

[03700780650675]

Moist Heat or Steam Sterilization

[03700780650675]

Moist Heat or Steam Sterilization

[03700780650675]

Moist Heat or Steam Sterilization

[03700780650675]

Moist Heat or Steam Sterilization

[03700780650675]

Moist Heat or Steam Sterilization

[03700780650675]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-10
• Device Publish Date: 2024-09-02

On-Brand Devices [Erisma®-MIS]

• 03700780644100: MIS PRE-LORDOSED ROD
• 03700780644094: MIS PRE-LORDOSED ROD
• 03700780644087: MIS PRE-LORDOSED ROD
• 03700780650323: LATERAL MIS UNIPLANAR SCREW
• 03700780650316: LATERAL MIS UNIPLANAR SCREW
• 03700780650309: LATERAL MIS UNIPLANAR SCREW
• 03700780650293: LATERAL MIS UNIPLANAR SCREW
• 03700780651306: LATERAL MIS UNIPLANAR SCREW
• 03700780651290: LATERAL MIS UNIPLANAR SCREW
• 03700780651283: LATERAL MIS UNIPLANAR SCREW
• 03700780651276: LATERAL MIS UNIPLANAR SCREW
• 03700780651269: LATERAL MIS UNIPLANAR SCREW
• 03700780651252: LATERAL MIS UNIPLANAR SCREW
• 03700780651245: LATERAL MIS UNIPLANAR SCREW
• 03700780651238: LATERAL MIS UNIPLANAR SCREW
• 03700780651221: LATERAL MIS UNIPLANAR SCREW
• 03700780651214: LATERAL MIS UNIPLANAR SCREW
• 03700780651207: LATERAL MIS UNIPLANAR SCREW
• 03700780651191: LATERAL MIS UNIPLANAR SCREW
• 03700780651177: LATERAL MIS UNIPLANAR SCREW
• 03700780651146: LATERAL MIS UNIPLANAR SCREW
• 03700780651139: LATERAL MIS UNIPLANAR SCREW
• 03700780651108: LATERAL MIS UNIPLANAR SCREW
• 03700780651092: LATERAL MIS UNIPLANAR SCREW
• 03700780651078: LATERAL MIS UNIPLANAR SCREW
• 03700780651061: LATERAL MIS UNIPLANAR SCREW
• 03700780651047: LATERAL MIS UNIPLANAR SCREW
• 03700780651030: LATERAL MIS UNIPLANAR SCREW
• 03700780651016: LATERAL MIS UNIPLANAR SCREW
• 03700780650996: LATERAL MIS UNIPLANAR SCREW
• 03700780650989: LATERAL MIS UNIPLANAR SCREW
• 03700780650972: LATERAL MIS UNIPLANAR SCREW
• 03700780650958: LATERAL MIS UNIPLANAR SCREW
• 03700780650934: LATERAL MIS UNIPLANAR SCREW
• 03700780650927: LATERAL MIS UNIPLANAR SCREW
• 03700780650910: LATERAL MIS UNIPLANAR SCREW
• 03700780650903: LATERAL MIS UNIPLANAR SCREW
• 03700780650897: LATERAL MIS UNIPLANAR SCREW
• 03700780650828: LATERAL MIS UNIPLANAR SCREW
• 03700780650811: LATERAL MIS UNIPLANAR SCREW
• 03700780650804: LATERAL MIS UNIPLANAR SCREW
• 03700780650798: LATERAL MIS UNIPLANAR SCREW
• 03700780650781: LATERAL MIS UNIPLANAR SCREW
• 03700780650774: LATERAL MIS UNIPLANAR SCREW
• 03700780650767: LATERAL MIS UNIPLANAR SCREW
• 03700780650750: LATERAL MIS UNIPLANAR SCREW
• 03700780650743: LATERAL MIS UNIPLANAR SCREW
• 03700780650736: LATERAL MIS UNIPLANAR SCREW
• 03700780650729: LATERAL MIS UNIPLANAR SCREW
• 03700780650712: LATERAL MIS UNIPLANAR SCREW