Erisma®-LP 13018580

GUDID 03700780615360

MIS CANNULATED POLYAXIAL SCREW

CLARIANCE

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 03700780615360
• NIH Device Record Key: 5eb21a94-ed18-498e-b784-aa2a57188589
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Erisma®-LP
• Version Model Number: 13018580
• Catalog Number: 13018580
• 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

Device Dimensions

• Length: 80 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8.5 Millimeter
• Length: 80 Millimeter
• Outer Diameter: 8.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700780615360 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162367

FDA Product Code

• NKB: Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Sterilization

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

[03700780615360]

Moist Heat or Steam Sterilization

[03700780615360]

Moist Heat or Steam Sterilization

[03700780615360]

Moist Heat or Steam Sterilization

[03700780615360]

Moist Heat or Steam Sterilization

[03700780615360]

Moist Heat or Steam Sterilization

[03700780615360]

Moist Heat or Steam Sterilization

[03700780615360]

Moist Heat or Steam Sterilization

[03700780615360]

Moist Heat or Steam Sterilization

[03700780615360]

Moist Heat or Steam Sterilization

[03700780615360]

Moist Heat or Steam Sterilization

[03700780615360]

Moist Heat or Steam Sterilization

[03700780615360]

Moist Heat or Steam Sterilization

[03700780615360]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-11-11
• Device Publish Date: 2018-02-12

On-Brand Devices [Erisma®-LP]

• 03700780638833: ROD HOLDER
• 03700780630165: DOUBLE BREAKING LEVER
• 03700780634385: POLYAXIAL REDUCTION SCREW
• 03700780618255: POLYAXIAL REDUCTION SCREW
• 03700780644056: ERISMA-LP CANNULATED SCREWDRIVER
• 03700780638147: UNIPLANAR SCREW
• 03700780638123: UNIPLANAR SCREW
• 03700780638116: UNIPLANAR SCREW
• 03700780638109: UNIPLANAR SCREW
• 03700780649693: UNIPLANAR SCREW
• 03700780649686: UNIPLANAR SCREW
• 03700780649679: UNIPLANAR SCREW
• 03700780649662: UNIPLANAR SCREW
• 03700780649655: UNIPLANAR SCREW
• 03700780649648: UNIPLANAR SCREW
• 03700780649631: UNIPLANAR SCREW
• 03700780649624: UNIPLANAR SCREW
• 03700780649617: UNIPLANAR SCREW
• 03700780649600: UNIPLANAR SCREW
• 03700780649594: UNIPLANAR SCREW
• 03700780649587: UNIPLANAR SCREW
• 03700780649570: UNIPLANAR SCREW
• 03700780643912: UNIPLANAR SCREW
• 03700780638697: UNIPLANAR SCREW
• 03700780638680: UNIPLANAR SCREW
• 03700780638673: UNIPLANAR SCREW
• 03700780638666: UNIPLANAR SCREW
• 03700780638659: UNIPLANAR SCREW
• 03700780638642: UNIPLANAR SCREW
• 03700780638635: UNIPLANAR SCREW
• 03700780638628: UNIPLANAR SCREW
• 03700780638611: UNIPLANAR SCREW
• 03700780638604: UNIPLANAR SCREW
• 03700780638598: UNIPLANAR SCREW
• 03700780638581: UNIPLANAR SCREW
• 03700780638574: UNIPLANAR SCREW
• 03700780638567: UNIPLANAR SCREW
• 03700780638550: UNIPLANAR SCREW
• 03700780638543: UNIPLANAR SCREW
• 03700780638154: UNIPLANAR SCREW
• 03700780638130: UNIPLANAR SCREW
• 03700780638093: UNIPLANAR SCREW
• 03700780638086: UNIPLANAR SCREW
• 03700780638079: UNIPLANAR SCREW
• 03700780638062: UNIPLANAR SCREW
• 03700780638055: UNIPLANAR SCREW
• 03700780638048: UNIPLANAR SCREW
• 03700780638031: UNIPLANAR SCREW
• 03700780638024: UNIPLANAR SCREW
• 03700780638017: UNIPLANAR SCREW