NBX 8107-00-00

GUDID B488810700000

NON-BRIDGING EXTERNAL FIXATOR SHOULDER

NUTEK ORTHOPAEDICS INC

External orthopaedic fixation system, single-use, sterile

• Primary Device ID: B488810700000
• NIH Device Record Key: 881246ed-5585-4a32-9e0e-7af2b8f2f84f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NBX
• Version Model Number: 8107-00-00
• Catalog Number: 8107-00-00
• Company DUNS: 787238620
• Company Name: NUTEK ORTHOPAEDICS INC
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: +1(954)779-1400
• Email: peter@nutekortho.com
• Phone: +1(954)779-1400
• Email: peter@nutekortho.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B488810700000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082833

FDA Product Code

• JEC: COMPONENT, TRACTION, INVASIVE

Sterilization

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

[B488810700000]

Radiation Sterilization

[B488810700000]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-02

On-Brand Devices [NBX]

• B488830700000: NON-BRIDGING EXTERNAL FIXATOR HAND SHORT
• B488820700000: NON-BRIDGING EXTERNAL FIXATOR HAND LONG
• B488810700000: NON-BRIDGING EXTERNAL FIXATOR SHOULDER
• B488800600000: NON-BRIDGING EXTERNAL FIXATOR WRIST