Ø4.5mm, Straight Hook 55-TH-0101

GUDID 00815362024492

Ø4.5mm, Straight Hook

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00815362024492
• NIH Device Record Key: 73ef9077-2fb7-4cec-a510-bd53599395fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ø4.5mm, Straight Hook
• Version Model Number: 55-TH-0101
• Catalog Number: 55-TH-0101
• 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: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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	00815362024492 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162300

FDA Product Code

• NKG: Posterior Cervical Screw System

Sterilization

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

[00815362024492]

Moist Heat or Steam Sterilization

[00815362024492]

Moist Heat or Steam Sterilization

[00815362024492]

Moist Heat or Steam Sterilization

[00815362024492]

Moist Heat or Steam Sterilization

[00815362024492]

Moist Heat or Steam Sterilization

[00815362024492]

Moist Heat or Steam Sterilization

[00815362024492]

Moist Heat or Steam Sterilization

[00815362024492]

Moist Heat or Steam Sterilization

[00815362024492]

Moist Heat or Steam Sterilization

[00815362024492]

Moist Heat or Steam Sterilization

[00815362024492]

Moist Heat or Steam Sterilization

[00815362024492]

Moist Heat or Steam Sterilization

[00815362024492]

Moist Heat or Steam Sterilization

[00815362024492]

Moist Heat or Steam Sterilization

[00815362024492]

Moist Heat or Steam Sterilization

[00815362024492]

Moist Heat or Steam Sterilization

[00815362024492]

Moist Heat or Steam Sterilization

[00815362024492]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-13
• Device Publish Date: 2019-05-03

Devices Manufactured by PRECISION SPINE, INC.

• 00840019972901 - Reform Ti Modular: 2025-02-03 Modular T25 Driver
• 00840019972918 - Reform Ti Modular: 2025-02-03 Stab & Grab T25 Driver
• 00840019972925 - Reform Ti Modular: 2025-02-03 Telescoping Blade - C/C
• 00840019972932 - Reform Ti Modular: 2025-02-03 Telescoping Blade - C/C
• 00840019972949 - Reform Ti Modular: 2025-02-03 M/L Blade Inserter
• 00840019972956 - Reform Ti Modular: 2025-02-03 T20 Blade Driver Assembly
• 00840019972963 - Reform Ti Modular: 2025-02-03 C/C Blade Inserter Assembly
• 00840019972970 - Reform Ti Modular: 2025-02-03 T20 Retractor Driver Assembly