Spinal Instruments 98722300

GUDID 03700780639182

HUDSON ADAPTOR

CLARIANCE

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03700780639182
• NIH Device Record Key: 4492e3a5-710e-4f53-a539-a7011e4b85ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spinal Instruments
• Version Model Number: 98722300
• Catalog Number: 98722300
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700780639182 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120469

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[03700780639182]

Moist Heat or Steam Sterilization

[03700780639182]

Moist Heat or Steam Sterilization

[03700780639182]

Moist Heat or Steam Sterilization

[03700780639182]

Moist Heat or Steam Sterilization

[03700780639182]

Moist Heat or Steam Sterilization

[03700780639182]

Moist Heat or Steam Sterilization

[03700780639182]

Moist Heat or Steam Sterilization

[03700780639182]

Moist Heat or Steam Sterilization

[03700780639182]

Moist Heat or Steam Sterilization

[03700780639182]

Moist Heat or Steam Sterilization

[03700780639182]

Moist Heat or Steam Sterilization

[03700780639182]

Moist Heat or Steam Sterilization

[03700780639182]

Moist Heat or Steam Sterilization

[03700780639182]

Moist Heat or Steam Sterilization

[03700780639182]

Moist Heat or Steam Sterilization

[03700780639182]

Moist Heat or Steam Sterilization

[03700780639182]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-18
• Device Publish Date: 2022-07-08

Devices Manufactured by CLARIANCE

• 03700780638109 - Erisma®-LP: 2024-08-14 UNIPLANAR SCREW
• 03700780638116 - Erisma®-LP: 2024-08-14 UNIPLANAR SCREW
• 03700780638123 - Erisma®-LP: 2024-08-14 UNIPLANAR SCREW
• 03700780638147 - Erisma®-LP: 2024-08-14 UNIPLANAR SCREW
• 03700780607969 - Erisma® Lp Spinal Fixation System: 2024-07-03 CLOSED OFFSET CONNECTOR
• 03700780607983 - Erisma® Lp Spinal Fixation System: 2024-07-03 CLOSED OFFSET CONNECTOR
• 03700780608003 - Erisma® Lp Spinal Fixation System: 2024-07-03 CLOSED OFFSET CONNECTOR
• 03700780615988 - Erisma® Deformity Spinal System: 2024-07-03 OPEN OFFSET CONNECTOR