Reform® Ti CT Modular MIS Pedicle Screw System 64-BK-0204

GUDID 00840019967617

Closed Ring Extended Tab Tulip Instrument Kit, Rod Inserter with Stop

PRECISION SPINE, INC.

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 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: 00840019967617
• NIH Device Record Key: 3be09f84-3143-4675-ab0b-db2a9d8b331d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reform® Ti CT Modular MIS Pedicle Screw System
• Version Model Number: 64-BK-0204
• Catalog Number: 64-BK-0204
• Company DUNS: 079398589
• Company Name: PRECISION SPINE, INC.
• Device Count: 1
• DM Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840019967617 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150856

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[00840019967617]

Moist Heat or Steam Sterilization

[00840019967617]

Moist Heat or Steam Sterilization

[00840019967617]

Moist Heat or Steam Sterilization

[00840019967617]

Moist Heat or Steam Sterilization

[00840019967617]

Moist Heat or Steam Sterilization

[00840019967617]

Moist Heat or Steam Sterilization

[00840019967617]

Moist Heat or Steam Sterilization

[00840019967617]

Moist Heat or Steam Sterilization

[00840019967617]

Moist Heat or Steam Sterilization

[00840019967617]

Moist Heat or Steam Sterilization

[00840019967617]

Moist Heat or Steam Sterilization

[00840019967617]

Moist Heat or Steam Sterilization

[00840019967617]

Moist Heat or Steam Sterilization

[00840019967617]

Moist Heat or Steam Sterilization

[00840019967617]

Moist Heat or Steam Sterilization

[00840019967617]

Moist Heat or Steam Sterilization

[00840019967617]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-15
• Device Publish Date: 2023-08-07

On-Brand Devices [Reform® Ti CT Modular MIS Pedicle Screw System]

• 00840019967679: Ring Remover, Open / Closed
• 00840019967662: Dual Tab Breaker, Open / Closed
• 00840019967655: Tulip Manipulator, Open / Closed
• 00840019967631: Counter Torque Wrench, Full Length
• 00840019967624: Modular MIS Extended Tab Tulip, Closed Ring
• 00840019967617: Closed Ring Extended Tab Tulip Instrument Kit, Rod Inserter with Stop
• 00840019967600: Closed Ring Extended Tab Tulip Instrument Kit, Pass Thru Rod Inserter
• 00840019967594: Closed Extended Tab Tulip Kit
• 00840019967587: Standard/Reduction/Closed Ring Extended Tab Tulip Implant Kit
• 00840019967570: Closed Ring Extended Tab Tulip Implant Kit