Spinal Instrument 98770000

GUDID 03700780639199

SCREW HOLDER FOR MOTORIZED SCREWDRIVER

CLARIANCE

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03700780639199
• NIH Device Record Key: d0efbaaa-abae-4303-9e07-d437c35b6d3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spinal Instrument
• Version Model Number: 98770000
• Catalog Number: 98770000
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700780639199 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153326

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[03700780639199]

Moist Heat or Steam Sterilization

[03700780639199]

Moist Heat or Steam Sterilization

[03700780639199]

Moist Heat or Steam Sterilization

[03700780639199]

Moist Heat or Steam Sterilization

[03700780639199]

Moist Heat or Steam Sterilization

[03700780639199]

Moist Heat or Steam Sterilization

[03700780639199]

Moist Heat or Steam Sterilization

[03700780639199]

Moist Heat or Steam Sterilization

[03700780639199]

Moist Heat or Steam Sterilization

[03700780639199]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-27
• Device Publish Date: 2022-07-19

On-Brand Devices [Spinal Instrument]

• 03700780630844: ROUNDED DISTRACTOR (H 11,5 MM - L 300 MM)
• 03700780630837: ROUNDED DISTRACTOR (H 10,5 MM - L 300 MM)
• 03700780630820: ROUNDED DISTRACTOR (H 9,5 MM - L 300 MM)
• 03700780630813: ROUNDED DISTRACTOR (H 8,5 MM - L 300 MM)
• 03700780630806: ROUNDED DISTRACTOR (H 7,5 MM - L 300 MM)
• 03700780630967: Rod Gripper
• 03700780630950: HEXAGONAL WRENCH
• 03700780612826: Compression Forceps
• 03700780639175: SLAP HAMMER (M)
• 03700780639168: SLAP HAMMER (L)
• 03700780639199: SCREW HOLDER FOR MOTORIZED SCREWDRIVER
• 03700780639205: SLAP HAMMER
• 03700780643776: ERISMA-LP NAV CANNULATED PROBE
• 03700780643769: PALM HANDLE FOR PERSUADER
• 03700780643783: ANGULATED CAGE HOLDER
• 03700780643813: ERISMA-LP EVO ROD CUTTER TABLE SUPP. CLAMP
• 03700780643806: ERISMA-LP EVO ROD CUTTER TABLE SUPPORT
• 03700780643790: ERISMA-LP EVO ROD CUTTER HANDLE
• 03700780643578: ERISMA-LP EVO ROD CUTTER