TDX

GUDID 18257200016280

INSTRUMENT CASE ASSEMBLY

ORTHOFIX INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 18257200016280
• NIH Device Record Key: 32d76e59-f148-43a6-a637-bf2d1aaefd2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TDX
• Version Model Number: 16-0001
• Company DUNS: 927083808
• Company Name: ORTHOFIX 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	18257200016280 [Primary]

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[18257200016280]

Moist Heat or Steam Sterilization

[18257200016280]

Moist Heat or Steam Sterilization

[18257200016280]

Moist Heat or Steam Sterilization

[18257200016280]

Moist Heat or Steam Sterilization

[18257200016280]

Moist Heat or Steam Sterilization

[18257200016280]

Moist Heat or Steam Sterilization

[18257200016280]

Moist Heat or Steam Sterilization

[18257200016280]

Moist Heat or Steam Sterilization

[18257200016280]

Moist Heat or Steam Sterilization

[18257200016280]

Moist Heat or Steam Sterilization

[18257200016280]

Moist Heat or Steam Sterilization

[18257200016280]

Moist Heat or Steam Sterilization

[18257200016280]

Moist Heat or Steam Sterilization

[18257200016280]

Moist Heat or Steam Sterilization

[18257200016280]

Moist Heat or Steam Sterilization

[18257200016280]

Moist Heat or Steam Sterilization

[18257200016280]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-11
• Device Publish Date: 2020-02-03

On-Brand Devices [TDX]

• 18257200093793: TDX STABILIATION SYSTEM INSTRUMENT CASE (16-0010)
• 18257200016280: INSTRUMENT CASE ASSEMBLY