NuFix II NFII-600C

GUDID B946NFII600C0

NuFix II Cannulated Blade Rev. 01

NUTECH SPINE, INC.

General internal orthopaedic fixation system implantation kit

• Primary Device ID: B946NFII600C0
• NIH Device Record Key: 3f2ae362-3d92-42de-a35e-14dc4ca40848
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuFix II
• Version Model Number: 01
• Catalog Number: NFII-600C
• Company DUNS: 080867996
• Company Name: NUTECH SPINE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B946NFII600C0 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

[B946NFII600C0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-02
• Device Publish Date: 2020-09-24

On-Brand Devices [NuFix II]

• B946NFII600CIR0: NuFix II Cannulated Blade
• B946NFII600C0: NuFix II Cannulated Blade Rev. 01
• B946NFII6000: NuFix II Non-Cannulated Blade
• B946NFII500IR0: NuFix II Inserter
• B946NFII5000: NuFix II Inserter Rev. 01
• B946NFII4020: NuFix II Drill, 5.0mm Rev. 01
• B946NFII300IR0: NuFix II Drill Guide
• B946NFII3000: NuFix II Drill Guide Rev. 01
• B946NFII200IR0: Drill Bushing Center Hole
• B946NFII200DIR0: Drill Bushing Two Holes
• B946NFII200D0: Drill Bushing Two Holes Rev. 01
• B946NFII2000: Drill Bushing Center Hole Rev. 01
• B946024000070: NuFix II Drill, 4.5mm - Stepped, Undersized
• B946024000060: NuFix II Drill, 4.5mm - Stepped
• B946024000050: NuFix II Drill, 4.5mm-Tapered, Undersized
• B946024000040: NuFix II Drill, 4.5mm - Tapered
• B946024000030: NuFix II Broach
• B946024000010: NuFix II Drill, 4.5mm
• B946021000010: NuFix II Go/No-Go Gage